Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2019 | Jul. 31, 2019 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | CHRS | |
Entity Registrant Name | Coherus BioSciences, Inc. | |
Entity Central Index Key | 0001512762 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Current Reporting Status | Yes | |
Entity Common Stock, Shares Outstanding | 69,763,968 | |
Entity File Number | 001-36721 | |
Entity Tax Identification Number | 273615821 | |
Entity Address, Address Line One | 333 Twin Dolphin Drive | |
Entity Address, Address Line Two | Suite 600 | |
Entity Address, City or Town | Redwood City | |
Entity Address, State or Province | California | |
Entity Address, Postal Zip Code | 94065 | |
City Area Code | 650 | |
Local Phone Number | 649-3530 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 | [1] |
Current assets: | |||
Cash and cash equivalents | $ 105,927 | $ 72,356 | |
Investments in marketable securities | 5,991 | 0 | |
Restricted cash | 50 | 50 | |
Trade receivables, net | 77,385 | 0 | |
Inventory | 4,333 | 1,659 | |
Prepaid manufacturing | 6,748 | 7,906 | |
Other prepaid and other assets | 5,196 | 2,462 | |
Total current assets | 205,630 | 84,433 | |
Property and equipment, net | 5,646 | 6,660 | |
Inventory, non-current | 18,465 | 4,012 | |
Operating lease right-of-use assets | 6,353 | 0 | |
Intangible assets | 2,620 | 2,620 | |
Goodwill | 943 | 943 | |
Restricted cash, non-current | 785 | 785 | |
Other assets, non-current | 14 | 14 | |
Total assets | 240,456 | 99,467 | |
Current liabilities: | |||
Accounts payable | 19,223 | 15,294 | |
Accounts payable - related parties | 50 | 0 | |
Accrued rebates, fees and reserve | 20,650 | 0 | |
Accrued compensation | 10,810 | 10,540 | |
Accrued liabilities | 8,295 | 7,008 | |
Other liabilities | 2,198 | 419 | |
Total current liabilities | 61,226 | 33,261 | |
Contingent consideration, non-current | 64 | 60 | |
Convertible notes | 77,916 | 77,319 | |
Convertible notes - related parties | 25,972 | 25,773 | |
Term loan | 73,286 | 0 | |
Lease liabilities, non-current | 5,977 | 0 | |
Other liabilities, non-current | 0 | 1,645 | |
Total liabilities | 244,441 | 138,058 | |
Commitments and contingencies (Note 8) | |||
Stockholders’ deficit: | |||
Preferred stock | |||
Common stock | 7 | 7 | |
Additional paid-in capital | 977,787 | 946,515 | |
Accumulated other comprehensive loss | (511) | (282) | |
Accumulated deficit | (981,268) | (984,831) | |
Total stockholders' deficit | (3,985) | (38,591) | |
Total liabilities and stockholders’ deficit | $ 240,456 | $ 99,467 | |
[1] | The consolidated balance sheet as of December 31, 2018 has been derived from the audited consolidated balance sheet included in the Company’s 2018 Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2019. |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Revenue: | ||||
Net product revenue | $ 83,433,000 | $ 0 | $ 120,531,000 | $ 0 |
Operating expenses: | ||||
Cost of goods sold | 601,000 | 0 | 2,826,000 | 0 |
Research and development (includes related party of $50 and $0 for the three months ended June 30, 2019 and 2018, respectively; and $50 and $1,479 for the six months ended June 30, 2019 and 2018, respectively) | 18,883,000 | 26,519,000 | 37,672,000 | 51,974,000 |
Selling, general and administrative (includes related party of $1 and $66 for the three months ended June 30, 2019 and 2018, respectively; and $1 and $100 for the six months ended June 30, 2019 and 2018, respectively) | 36,456,000 | 18,391,000 | 69,139,000 | 34,968,000 |
Total operating expenses | 55,940,000 | 44,910,000 | 109,637,000 | 86,942,000 |
Income (loss) from operations | 27,493,000 | (44,910,000) | 10,894,000 | (86,942,000) |
Interest expense (includes related party of $613 and $604 for the three months ended June 30, 2019 and 2018, respectively; and $1,224 and $1,206 for the six months ended June 30, 2019 and 2018, respectively) | (4,433,000) | (2,417,000) | (8,649,000) | (4,825,000) |
Other income, net | 558,000 | 3,642,000 | 1,369,000 | 3,780,000 |
Net income (loss) before income taxes | 23,618,000 | (43,685,000) | 3,614,000 | (87,987,000) |
Income tax provision | 51,000 | 0 | 51,000 | 0 |
Net income (loss) | 23,567,000 | (43,685,000) | 3,563,000 | (87,987,000) |
Net loss attributable to non-controlling interest | 0 | 47,000 | 0 | 52,000 |
Net income (loss) attributable to Coherus | $ 23,567,000 | $ (43,638,000) | $ 3,563,000 | $ (87,935,000) |
Net income (loss) per share attributable to Coherus: | ||||
Basic | $ 0.34 | $ (0.68) | $ 0.05 | $ (1.42) |
Diluted | $ 0.32 | $ (0.68) | $ 0.05 | $ (1.42) |
Weighted-average number of shares used in computing net income (loss) per share attributable to Coherus: | ||||
Basic | 69,479,016 | 63,960,567 | 69,310,791 | 62,051,912 |
Diluted | 72,963,972 | 63,960,567 | 72,281,564 | 62,051,912 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Operations (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Selling, general and administrative expenses from transactions with related party | $ 1 | $ 66 | $ 1 | $ 100 |
Interest expense from transactions with related party | 613 | 604 | 1,224 | 1,206 |
Research and Development Expense | ||||
Research and development from transactions with related party | $ 50 | $ 0 | $ 50 | $ 1,479 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Comprehensive Income (Loss) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Statement Of Income And Comprehensive Income [Abstract] | ||||
Net income (loss) | $ 23,567 | $ (43,685) | $ 3,563 | $ (87,987) |
Other comprehensive income (loss): | ||||
Unrealized gain on available-for-sale securities, net of tax | 0 | 1 | 0 | 0 |
Foreign currency translation adjustments, net of tax | (93) | 226 | (229) | 213 |
Comprehensive income (loss) | 23,474 | (43,458) | 3,334 | (87,774) |
Comprehensive loss attributable to non-controlling interest | 0 | 47 | 0 | 52 |
Comprehensive income (loss) attributable to Coherus | $ 23,474 | $ (43,411) | $ 3,334 | $ (87,722) |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Total | Common Stock Offering | 2018 Bonus Payout | Common Stock | Common StockCommon Stock Offering | Common StockRestricted Stock Units | Common Stock2018 Bonus Payout | Additional Paid-In Capital | Additional Paid-In CapitalCommon Stock Offering | Additional Paid-In Capital2018 Bonus Payout | Accumulated Other Comprehensive Loss | Accumulated Deficit | Total Coherus Stockholders' Equity (Deficit) | Total Coherus Stockholders' Equity (Deficit)Common Stock Offering | Noncontrolling Interest | |
Beginning Balances at Dec. 31, 2017 | $ 30,535 | $ 6 | $ 808,060 | $ (750) | $ (775,492) | $ 31,824 | $ (1,289) | |||||||||
Beginning Balances, Shares at Dec. 31, 2017 | 59,840,467 | |||||||||||||||
Issuance of common stock | $ 1,748 | $ 1,748 | $ 1,748 | |||||||||||||
Issuance of common stock, Shares | 192,642 | |||||||||||||||
Issuance of common stock upon exercise of stock options | 225 | 225 | 225 | |||||||||||||
Issuance of common stock upon exercise of stock options, Shares | 121,116 | |||||||||||||||
Stock-based compensation expense | 8,720 | 8,720 | 8,720 | |||||||||||||
Other comprehensive loss - unrealized gain in marketable securities | (1) | (1) | (1) | |||||||||||||
Other comprehensive income - cumulative translation adjustment | (13) | (13) | (13) | |||||||||||||
Distributions to non-controlling interest | (5) | (5) | ||||||||||||||
Net income (loss) attributable to Coherus | (44,297) | (44,297) | (44,297) | |||||||||||||
Ending Balances at Mar. 31, 2018 | (3,088) | $ 6 | 818,753 | (764) | (819,789) | (1,794) | (1,294) | |||||||||
Ending Balances, Shares at Mar. 31, 2018 | 60,154,225 | |||||||||||||||
Beginning Balances at Dec. 31, 2017 | 30,535 | $ 6 | 808,060 | (750) | (775,492) | 31,824 | (1,289) | |||||||||
Beginning Balances, Shares at Dec. 31, 2017 | 59,840,467 | |||||||||||||||
Other comprehensive loss - unrealized gain in marketable securities | 0 | |||||||||||||||
Other comprehensive income - cumulative translation adjustment | 213 | |||||||||||||||
Net income (loss) attributable to Coherus | (87,935) | |||||||||||||||
Ending Balances at Jun. 30, 2018 | 61,831 | $ 7 | 927,129 | (537) | (863,427) | 63,172 | (1,341) | |||||||||
Ending Balances, Shares at Jun. 30, 2018 | 67,743,031 | |||||||||||||||
Beginning Balances at Mar. 31, 2018 | (3,088) | $ 6 | 818,753 | (764) | (819,789) | (1,794) | (1,294) | |||||||||
Beginning Balances, Shares at Mar. 31, 2018 | 60,154,225 | |||||||||||||||
Issuance of common stock | 98,639 | $ 1 | 98,638 | $ 98,639 | ||||||||||||
Issuance of common stock, Shares | 89,296 | 7,399,411 | 5,000 | |||||||||||||
Issuance of common stock upon exercise of stock options | 284 | 284 | 284 | |||||||||||||
Issuance of common stock upon ESPP purchase | 764 | 764 | 764 | |||||||||||||
Issuance of common stock upon ESPP purchase, Shares | 95,099 | |||||||||||||||
Stock-based compensation expense | 8,690 | 8,690 | 8,690 | |||||||||||||
Other comprehensive loss - unrealized gain in marketable securities | 1 | 1 | 1 | |||||||||||||
Other comprehensive income - cumulative translation adjustment | 226 | 226 | 226 | |||||||||||||
Distributions to non-controlling interest | (47) | (47) | ||||||||||||||
Net income (loss) attributable to Coherus | (43,638) | (43,638) | (43,638) | |||||||||||||
Ending Balances at Jun. 30, 2018 | 61,831 | $ 7 | 927,129 | (537) | (863,427) | $ 63,172 | $ (1,341) | |||||||||
Ending Balances, Shares at Jun. 30, 2018 | 67,743,031 | |||||||||||||||
Beginning Balances at Dec. 31, 2018 | (38,591) | [1] | $ 7 | 946,515 | (282) | (984,831) | ||||||||||
Beginning Balances, Shares at Dec. 31, 2018 | 68,302,681 | |||||||||||||||
Issuance of common stock | $ 8,228 | $ 1,350 | $ 8,228 | $ 1,350 | ||||||||||||
Issuance of common stock, Shares | 761,130 | 22,195 | 109,168 | |||||||||||||
Issuance of common stock upon exercise of stock options | 825 | 825 | ||||||||||||||
Issuance of common stock upon exercise of stock options, Shares | 143,523 | |||||||||||||||
Stock-based compensation expense | 9,813 | 9,813 | ||||||||||||||
Other comprehensive income - cumulative translation adjustment | (136) | (136) | ||||||||||||||
Net income (loss) attributable to Coherus | (20,004) | (20,004) | ||||||||||||||
Ending Balances at Mar. 31, 2019 | (38,515) | $ 7 | 966,731 | (418) | (1,004,835) | |||||||||||
Ending Balances, Shares at Mar. 31, 2019 | 69,338,697 | |||||||||||||||
Beginning Balances at Dec. 31, 2018 | (38,591) | [1] | $ 7 | 946,515 | (282) | (984,831) | ||||||||||
Beginning Balances, Shares at Dec. 31, 2018 | 68,302,681 | |||||||||||||||
Other comprehensive loss - unrealized gain in marketable securities | 0 | |||||||||||||||
Other comprehensive income - cumulative translation adjustment | (229) | |||||||||||||||
Net income (loss) attributable to Coherus | 3,563 | |||||||||||||||
Ending Balances at Jun. 30, 2019 | (3,985) | $ 7 | 977,787 | (511) | (981,268) | |||||||||||
Ending Balances, Shares at Jun. 30, 2019 | 69,627,148 | |||||||||||||||
Beginning Balances at Mar. 31, 2019 | (38,515) | $ 7 | 966,731 | (418) | (1,004,835) | |||||||||||
Beginning Balances, Shares at Mar. 31, 2019 | 69,338,697 | |||||||||||||||
Issuance of common stock, Shares | 108,374 | |||||||||||||||
Issuance of common stock upon exercise of stock options | 674 | 674 | ||||||||||||||
Issuance of common stock upon ESPP purchase | 1,878 | 1,878 | ||||||||||||||
Issuance of common stock upon ESPP purchase, Shares | 180,077 | |||||||||||||||
Stock-based compensation expense | 8,504 | 8,504 | ||||||||||||||
Other comprehensive loss - unrealized gain in marketable securities | 0 | |||||||||||||||
Other comprehensive income - cumulative translation adjustment | (93) | (93) | ||||||||||||||
Net income (loss) attributable to Coherus | 23,567 | 23,567 | ||||||||||||||
Ending Balances at Jun. 30, 2019 | $ (3,985) | $ 7 | $ 977,787 | $ (511) | $ (981,268) | |||||||||||
Ending Balances, Shares at Jun. 30, 2019 | 69,627,148 | |||||||||||||||
[1] | The consolidated balance sheet as of December 31, 2018 has been derived from the audited consolidated balance sheet included in the Company’s 2018 Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2019. |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Operating activities | ||
Net income (loss) | $ 3,563 | $ (87,987) |
Adjustments to reconcile net income (loss) to net cash used in operating activities: | ||
Depreciation and amortization | 1,365 | 1,824 |
Remeasurement of fair-value contingent consideration | 4 | (3,195) |
Stock-based compensation expense | 17,486 | 17,410 |
Non-cash accretion of discount on marketable securities | (127) | (114) |
Non-cash interest expense from amortization of debt discount | 1,127 | 725 |
Excess and obsolete inventory | 410 | 0 |
Non-cash operating lease expense | 818 | 0 |
Changes in operating assets and liabilities: | ||
Trade receivables, net | (77,385) | 0 |
Inventory | (16,706) | 0 |
Prepaid manufacturing | 1,158 | 4,699 |
Other prepaid and current assets | (2,630) | 893 |
Accounts payable | 4,024 | (2,333) |
Accounts payable - related parties | 50 | (233) |
Accrued rebates, fees and reserve | 20,650 | 0 |
Accrued compensation | 1,620 | 3,111 |
Accrued and other liabilities | 1,317 | (3,697) |
Lease liabilities | (1,020) | 0 |
Other liabilities, non-current | (30) | (217) |
Net cash used in operating activities | (44,306) | (69,114) |
Investing activities | ||
Purchases of property and equipment | (517) | (86) |
Purchases of investments in marketable securities | (14,864) | (42,869) |
Proceeds from maturities of investments in marketable securities | 9,000 | 13,170 |
Net cash used in investing activities | (6,381) | (29,785) |
Financing activities | ||
Proceeds from common stock offering, net of underwriters discounts, commissions and offering costs | 8,153 | 100,497 |
Proceeds from term loan, net of issuance costs | 73,061 | 0 |
Proceeds from issuance of common stock upon exercise of stock options | 1,395 | 509 |
Proceeds from ESPP purchase | 1,878 | 764 |
Net cash provided by financing activities | 84,487 | 101,770 |
Effect of exchange rate changes in cash, cash equivalents and restricted cash | (229) | 213 |
Net increase in cash, cash equivalents and restricted cash | 33,571 | 3,084 |
Cash, cash equivalents and restricted cash at beginning of period | 73,191 | 127,756 |
Cash, cash equivalents and restricted cash at end of period | 106,762 | 130,840 |
Supplemental disclosure of cash flow information | ||
Non-cash 2018 bonus payment settled in common stock | $ 1,350 | $ 0 |
Organization and Operations
Organization and Operations | 6 Months Ended |
Jun. 30, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Organization and Operations | 1. Organization and Operations Description of the Business Coherus BioSciences, Inc. (the “Company”, “Coherus”, “we”, our” or “us”) is a commercial-stage biotherapeutics company, focused on the global biosimilar market. The Company’s headquarters and laboratories are located in Redwood City, California and in Camarillo, California, respectively. On September 25, 2018, the Company received regulatory approval for the marketing of UDENYCA ® ® ® Need to Raise Additional Capital As of June 30, 2019, the Company had an accumulated deficit of $981.3 million and cash and cash equivalents and short-term investments in marketable securities of $111.9 million. In January 2019, the Company issued and sold 761,130 shares of common stock at a weighted average price of $11.17 per share through its ATM Offering Program and received total net proceeds of $8.2 million (see Note 10). As of January 19, 2019, the Company’s Shelf Registration Statement expired and accordingly the ATM Program was terminated. The Company also entered into a credit agreement (the “Term Loan”) with affiliates of Healthcare Royalty Partners consisting of a six-year term loan facility for an aggregate principal of $75.0 million in January 2019. UDENYCA ® for at least 12 months following our financial statement issuance date . |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Summary of Significant Accounting Policies | 2. Basis of Presentation and Summary of Significant Accounting Policies Unaudited Condensed Consolidated Financial Statements The accompanying condensed consolidated financial statements include the accounts of Coherus and its wholly-owned subsidiaries as of June 30, 2019: Coherus Intermediate Corp, InteKrin Therapeutics Inc. (“InteKrin”), and InteKrin’s wholly-owned subsidiary, InteKrin Russia. Unless otherwise specified, references to the Company are references to Coherus and its consolidated subsidiaries. All intercompany transactions and balances have been eliminated upon consolidation. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the Securities Act of 1933, as amended (the “Securities Act”). Accordingly, they do not include all of the information and notes required by U.S. GAAP for complete financial statements. These unaudited condensed consolidated financial statements include all adjustments, consisting only of normal recurring accruals that the Company believes are necessary to fairly state the financial position and the results of the Company’s operations and cash flows for interim periods in accordance with U.S. GAAP. Interim-period results are not necessarily indicative of results of operations or cash flows for a full year or any subsequent interim period. The accompanying condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K filed with the SEC on February 28, 2019. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make judgements, estimates and assumptions that affect the reported amounts of assets, liabilities, equity, revenue and expenses, and related disclosures. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ from these estimates. Foreign Currency The functional currency of InteKrin Russia, which the Company acquired in February 2014, is the Russian Ruble. Accordingly, the financial statements of this subsidiary are translated into U.S. dollars using appropriate exchange rates. Unrealized gains or losses on translation are recognized in accumulated other comprehensive loss in the condensed consolidated balance sheet. The foreign exchange gains and losses recorded in other income, net in the condensed consolidated statements of operations for the three months ended June 30, 2019 and 2018, were a net gain of $61,000 and a net loss of $270,000, respectively, and for the six months ended June 30, 2019 and 2018 were a net gain of $230,000 and a net loss of $278,000, respectively. Segment Reporting The Company operates and manages its business as one reportable and operating segment, which is the business of developing and commercializing biosimilar products, and, as part of the InteKrin acquisition, small molecules. The Company’s chief executive officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for purposes of allocating resources and evaluating financial performance. Long-lived assets are primarily maintained in the United States of America. See Note 6 for disclosures about product sales and revenue from major customers. Cash, Cash Equivalents and Restricted Cash Cash, cash equivalents and restricted cash is comprised of cash and highly liquid investments with remaining maturities of 90 days or less at the date of purchase. The Company limits cash investments to financial institutions with high credit standings; therefore, management believes that there is no significant exposure to any credit risk in the Company’s cash, cash equivalents and restricted cash. The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets and which, in aggregate, represent the amount reported in the condensed consolidated statements of cash flows. June 30, June 30, 2019 2018 Cash and cash equivalents $ 105,927 $ 130,005 Restricted cash 50 50 Restricted cash - non-current 785 785 Total cash, cash equivalents and restricted cash $ 106,762 $ 130,840 Restricted cash consists of cash held in money market accounts at banks. The restricted cash is used as collateral against the Company’s corporate credit cards and is classified as current; restricted cash – non-current is held to cover the standby letter of credit issued by the Company’s landlord to drawdown on in the event the facility lease is breached. Trade Receivables Trade receivables are recorded net of allowances for chargebacks and cash discounts for prompt payment. The Company’s estimate of the allowance for doubtful accounts is based on an evaluation of the aging of its receivables. Trade receivable balances are written off against the allowance when it is probable that the receivable will not be collected. To date, the Company has determined that an allowance for doubtful accounts is not required. Investments in Marketable Securities Management determines the appropriate classification of investments in marketable securities at the time of purchase based upon management’s intent with regards to such investments and reevaluates such designation as of each balance sheet date. All investments in marketable securities are held as “available-for-sale” and are carried at the estimated fair value as determined based upon quoted market prices or pricing models for similar securities. The Company classifies investments in marketable securities as short-term when they have remaining contractual maturities of one year or less from the balance sheet date. Unrealized gains and losses are excluded from earnings and are reported as a component of accumulated comprehensive income (loss). Realized gains and losses and declines in value judged to be other than temporary, if any, on available-for-sale securities are included in other income, net, based on the specific identification method. Inventory Prior to the regulatory approval of its product candidates, the Company incurred expenses for the manufacture of drug products that could potentially be available to support the commercial launch of its products. The Company began to capitalize inventory costs associated with UDENYCA ® ® Inventory is stated at the lower of cost or estimated net realizable value with cost determined under the first-in first-out method. Inventory costs include third-party contract manufacturing, third-party packaging services, freight, labor costs for personnel involved in the manufacturing process and indirect overhead costs. The Company primarily uses actual costs to determine the cost basis for inventory. The determination of whether inventory costs will be realizable requires management review of the expiration dates of UDENYCA ® Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use assets, other liabilities, and lease liabilities, non-current in the condensed consolidated balance sheets. Right-of-use assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the present value of lease payments, the Company uses the incremental borrowing rate based on the information available at the lease commencement date. Lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise any such options. Lease expense is recognized on a straight-line basis over the expected lease term. Revenue Recognition The Company adopted ASU 2014-09, Revenue from Contracts with Customers (Topic 606), ASU 2014-09: ASU No. 2016-08, Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations ; ASU No. 2016-10, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing ; and ASU No. 2016-12, Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients , (collectively, the “New Revenue Standard”) on January 1, 2018 using the modified retrospective method. Topic 606 supersedes all previous revenue recognition requirements in accordance with generally accepted accounting principles. This standard applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. Under Topic 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration to which the entity is entitled to in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines is within the scope of Topic 606, it performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the performance obligation is satisfied. The Company only applies the five-step model to contracts when it is probable that it will collect the consideration it is entitled to in exchange for the goods or services it transferred to the customer. Net Product Revenue The Company sells UDENYCA ® ® ® ® to Healthcare Providers ® Product Sales Discounts and Allowances Revenues from product sales are recorded at the net sales price (“transaction price”), which includes estimates of variable consideration for which reserves are established and that result from chargebacks, rebates, co-pay assistance, prompt-payment discounts, returns and other allowances that are offered within contracts between the Company and its Customers, Healthcare Providers, payers and GPOs relating to the sales of UDENYCA ® Chargebacks: Chargebacks are discounts that occur when Healthcare Providers purchase directly from a Customer. Healthcare Providers, which belong to Public Health Service institutions, non-profit clinics, government entities, GPOs, and health maintenance organizations, generally purchase the product at a discounted price. The Customer, in turn, charges back to the Company the difference between the price initially paid by the Customer and the discounted price paid by the Healthcare Providers to the Customer. The allowance for chargebacks is based on an estimate of sales through to Healthcare Providers from the Customer. Discounts for Prompt Payment: The Company provides for prompt payment discounts to its Customers, which are recorded as a reduction in revenue in the same period that the related product revenue is recognized. Rebates: Rebates include mandated discounts under the Medicaid Drug Rebate Program, other government programs and commercial contracts. Rebate amounts owed after the final dispensing of the product to a benefit plan participant are based upon contractual agreements or legal requirements with these public sector benefit providers. Certain rebate amounts commensurate with share utilization of UDENYCA relative to other pegfilgrastim products. The accrual for rebates is based on statutory or contractual discount rates and expected utilization. The estimates for the expected utilization of rebates are based on Customer and commercially available payer data, as well as data collected from the Healthcare Providers, Customers, GPOs, and historical utilization rates. Rebates invoiced by payers, Healthcare Providers and GPOs are paid in arrears. If actual future rebates vary from estimates, the Company may need to adjust its accruals, which would affect net product revenue in the period of adjustment. Co-payment Assistance: Patients who have commercial insurance and meet certain eligibility requirements may receive co-payment assistance. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue. Product Returns: The Company offer to its Customers limited product return right, which is principally based upon damaged, defective or the product’s expiration date. Product return allowance is estimated and recorded at the time of sale. Other Allowances: The Company pays fees to Customers and GPOs for account management, data management and other administrative services. To the extent that the services received are distinct from the sale of products to the customer, these payments are classified in selling, general and administrative expense in the Company’s condensed consolidated statements of operations, otherwise they are included as a reduction to product revenue. Cost of Goods Sold Cost of goods sold consists primarily of third-party manufacturing, distribution, and overhead costs associated with UDENYCA ® ® ® On May 2, 2019, the Company and Amgen settled a trade secret action brought by Amgen. The Company will pay a mid-single digit royalty on net product revenue to Amgen beginning on July 1, 2019 for five years. Cost of goods sold for the six months ended June 30, 2019, included write-off of prepaid manufacturing costs of $1.3 million due to the cancellation of certain manufacturing reservations, and $0.4 million due to the write-off of excess and obsolete inventory. Research and Development Expense Research and development costs are charged to expense as incurred. Research and development expense includes, among other costs, salaries and other personnel-related costs, consultant fees, preclinical costs, cost to manufacture drug candidates and clinical trial costs and supplies, laboratory supplies costs and facility-related costs. Costs incurred under agreements with third parties are charged to expense as incurred in accordance with the specific contractual performance terms of such agreements. Costs of third parties include costs associated with manufacturing drug candidates, preclinical and clinical support activities. Advance payments for goods or services to be received in the future and utilized in research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are delivered or the services are received. The Company considers regulatory approval of product candidates to be uncertain, and product manufactured prior to regulatory approval may not be sold unless regulatory approval is obtained. The Company expenses manufacturing costs as incurred to research and development expense for product candidates prior to regulatory approval. If, and when, regulatory approval of a product is obtained, the Company will begin capitalizing manufacturing costs related to the approved product into inventory Comprehensive Income (Loss) Comprehensive income (loss) is composed of two components: net income (loss) and other comprehensive income (loss). Other comprehensive income (loss) refers to gains and losses that under U.S. GAAP are recorded as an element of stockholders’ equity (deficit), but are excluded from net income (loss). The Company’s other comprehensive income (loss) includes unrealized gains and losses from available-for-sale marketable securities and foreign currency translation adjustments for the six months ended June 30, 2019 and 2018. Net Income (Loss) per Share Attributable to Coherus Basic net income (loss) per share attributable to Coherus is calculated by dividing the net income (loss) attributable to Coherus by the weighted-average number of shares of common stock outstanding for the period, without consideration for potential dilutive common shares. Diluted net income (loss) per share is computed by dividing the net income (loss) per share by the weighted average number of common shares outstanding for the period plus any diluted potential common shares outstanding for the period determined using the treasury stock method for options, RSUs and ESPP and using the if-converted method for the convertible notes (see Note 11). Income Taxes The Company uses the liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company must then assess the likelihood that the resulting deferred tax assets will be realized. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. Due to the Company’s lack of earnings history, the net deferred tax assets have been fully offset by a valuation allowance. The Company recognizes uncertain income tax positions at the largest amount that is more likely than not to be sustained upon audit by the relevant taxing authority. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being sustained. The Company does not expect its unrecognized tax benefits to change significantly over the next twelve months. The Company’s policy is to recognize interest and/or penalties related to income tax matters in income tax expense. The Company had accrued no amounts for interest and penalties related to income tax matters in the Company’s consolidated balance sheet at June 30, 2019 and December 31, 2018. For the three and six months ended June 30, 2019, the Company recorded income tax provision of $51,000, which comprised of state taxes in jurisdictions outside of California for which the Company has a limited operating history. Income tax provision during interim periods is based on applying an estimated annual effective income tax rate to year-to-date income, plus any significant unusual or infrequently occurring items which are recorded in the interim period in accordance with ASC 740-270. The income tax provision for the three months ended June 30, 2019 differs from the U.S. federal statutory rate of 21% primarily due to effect of change in the valuation allowance against the Company’s federal deferred tax assets which reduced the Company’s net tax expense. The Company maintains a full valuation allowance against its net deferred tax assets due to the Company’s history of losses as of June 30, 2019. Recent Accounting Pronouncements The following are the recent accounting pronouncements adopted by the Company in 2019: In February 2016, the FASB issued ASU No. 2016-02, Leases Leases The impact of the adoption of Topic 842 on the accompanying condensed consolidated balance sheet as of January 1, 2019 was as follows (in thousands): December 31, 2018 Adjustments Due to the Adoption of Topic 842 January 1, 2019 Operating lease right-of-use asset $ — $ 7,172 $ 7,172 Operating lease liabilities: Other current liabilities ( 1) $ 419 $ 1,665 $ 2,084 Other lease liabilities, non-current ( 2) $ 1,645 $ 5,466 $ 7,111 ______________________________________________________ (1) Includes current portion of deferred rent and current portion of operating lease liabilities. (2) Non-current portion of deferred rent and operating lease liabilities. The impact of the adoption of Topic 842 on the accompanying condensed consolidated statement of operations as of and for the three and six months ended June 30, 2019 were as follows (in thousands): Three Months Ended June 30, 2019 Balance without As Reported Higher (Lower) the Adoption Research and development $ 18,883 $ 39 $ 18,922 Selling, general and administrative $ 36,456 $ 43 $ 36,499 Total operating expenses $ 55,940 $ 82 $ 56,022 Income from operations $ 27,493 $ (82 ) $ 27,411 Net income $ 23,567 $ (82 ) $ 23,485 Net income attributable to Coherus $ 23,567 $ (82 ) $ 23,485 Six Months Ended June 30, 2019 Balance without As Reported Higher (Lower) the Adoption Research and development $ 37,672 $ 83 $ 37,755 Selling, general and administrative $ 69,139 $ 87 $ 69,226 Total operating expenses $ 109,637 $ 170 $ 109,807 Income from operations $ 10,894 $ (170 ) $ 10,724 Net income $ 3,563 $ (170 ) $ 3,393 Net income attributable to Coherus $ 3,563 $ (170 ) $ 3,393 In June 2018, the FASB issued ASU No. 2018-07, Improvements to Nonemployee Share-Based Payment Accounting In August 2018, the SEC adopted amendments to certain disclosure requirements in Securities Act Release No. 33-10532, Disclosure Update and Simplification. January 1, 2019 and such adoption did not The following are the recent accounting pronouncements that the Company has not yet adopted: In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326) (ASU 2016-13). In January 2017, the FASB issued ASU No. 2017-04, Intangibles-Goodwill and Other: Simplifying the Test for Goodwill Impairment In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurements The Company has reviewed other recent accounting pronouncements and concluded they are either not applicable to the business or that no material effect is expected on the consolidated financial statements as a result of future adoption. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3. Fair Value Measurements Financial assets and liabilities are recorded at fair value. The carrying amounts of certain of the Company’s financial instruments, including cash and cash equivalents, restricted cash, investments in marketable securities, accounts receivable, accounts payable and other current liabilities approximate their fair value due to their short maturities. Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The accounting guidance describes a fair value hierarchy based on three levels of inputs that may be used to measure fair value, of which the first two are considered observable and the last is considered unobservable. These levels of inputs are the following: Level 1 — Quoted prices in active markets for identical assets or liabilities. Level 2 — Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. A financial instrument’s categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. The Company’s financial instruments consist of Level 1 and Level 2 assets, and Level 3 liabilities. Where quoted prices are available in an active market, securities are classified as Level 1. Level 1 assets consist of highly liquid money market funds. When quoted market prices are not available for the specific security, then the Company estimates the fair value by using quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant inputs are observable in the market or can be corroborated by observable market data for substantially the full term of the assets. Where applicable, these models project future cash flows and discount the future amounts to a present value using market-based observable inputs obtained from various third party data providers, including but not limited to, benchmark yields, interest rate curves, reported trades, broker/dealer quotes and market reference data. Level 2 assets consist of corporate notes and commercial paper. Level 2 inputs for the valuations are limited to quoted prices for similar assets or liabilities in active markets and inputs other than quoted prices that are observable for the asset or liability. In certain cases where there is limited activity or less transparency around inputs to valuation, securities are classified as Level 3. Level 3 liabilities consist of the contingent consideration. There were no transfers between Level 1, Level 2 and Level 3 during the periods presented. Financial assets and liabilities subject to fair value measurements on a recurring basis and the level of inputs used in such measurements are as follows (in thousands): Fair Value Measurements June 30, 2019 Total Level 1 Level 2 Level 3 Financial Assets: Money market funds $ 83,326 $ 83,326 $ — $ — Restricted cash (money market funds) 835 835 — — Corporate notes and commercial paper 12,573 — 12,573 — Total financial assets $ 96,734 $ 84,161 $ 12,573 $ — Financial Liabilities: Contingent consideration $ 64 $ — $ — $ 64 Fair Value Measurements December 31, 2018 Total Level 1 Level 2 Level 3 Financial Assets: Money market funds $ 71,062 $ 71,062 $ — $ — Restricted cash (money market funds) 835 835 — — Total financial assets $ 71,897 $ 71,897 $ — $ — Financial Liabilities: Contingent consideration $ 60 $ — $ — $ 60 Cash equivalents, investments in marketable securities, which are classified as available-for-sale securities, and restricted cash, consisted of the following (in thousands): June 30, 2019 Cost Unrealized Gain Unrealized (Loss) Estimated Fair Value Money market funds $ 83,326 $ — $ — $ 83,326 Corporate notes and commercial paper 6,582 — — 6,582 Classified as cash equivalents $ 89,908 $ — $ — $ 89,908 Corporate notes and commercial paper $ 5,991 $ — $ — $ 5,991 Classified as investments in marketable securities $ 5,991 $ — $ — $ 5,991 Restricted cash (money market funds) $ 835 $ — $ — $ 835 Classified as restricted cash $ 835 $ — $ — $ 835 December 31, 2018 Cost Unrealized Gain Unrealized (Loss) Estimated Fair Value Money market funds $ 71,062 $ — $ — $ 71,062 Classified as cash equivalents $ 71,062 $ — $ — $ 71,062 Restricted cash (money market funds) $ 835 $ — $ — $ 835 Classified as restricted cash $ 835 $ — $ — $ 835 As of June 30, 2019, the remaining contractual maturities of available-for-sale securities were less than one year. The average maturity of investments in marketable securities available-for-sale as of June 30, 2019 was approximately four months. The gross realized gains were $145,000 and $143,000 for the three months ended June 30, 2019 and 2018, respectively, and $257,000 and $226,000 for the six months ended June 30, 2019 and 2018, respectively, in the condensed consolidated statement of operations. There were no gross realized losses for the three and six months ended June 30, 2019 and 2018, in the condensed consolidated statement of operations. Contingent Consideration As part of the InteKrin acquisition in February 2014, the Company recognized contingent consideration associated with potential payments to be made to the former InteKrin stockholders upon (i) the first dosing of a human subject in the first Phase 2 Clinical Trial for CHS-131 ("Earn-Out Payment") and (ii) per a compound transaction agreement as defined in the purchase agreement (the “Compound Transaction Payment”). The contingent consideration related to the Earn-Out Payment was settled on March 6, 2015. The fair value measurement of the Compound Transaction Payment uses a probability-weighted discounted cash flow approach based on significant inputs not observable in the market and thus represents a Level 3 measurement within the fair value hierarchy. The compound transaction analysis as of June 30, 2019 applied a 20% risk-adjusted discount rate to measure the present value and also captured an additional 8% credit spread for counterparty credit risk given the cash payment. The expected cash flow is based on estimates provided by the Company’s management including the timing and probability of occurrence. The value of the consideration is tiered based on the value of a license or similar agreement with a third party and the timing of such agreement. Generally, increases or decreases in the probability of occurrence would result in a directionally similar impact in the fair value measurement of the Compound Transaction Payment and it is estimated that a 1% increase (decrease) in the probability of occurrence would result in an immaterial fair value fluctuation. The change in the fair value of the Compound Transaction Payment was recognized in other income, net within the condensed consolidated statement of operations of $0 and $3.4 million for the three months ended June 30, 2019 and 2018, respectively, and $4,000 and $3.2 million for the six months ended June 30, 2019 and 2018, respectively. The following table sets forth a summary of changes in the estimated fair value of the contingent consideration (in thousands): Balance as of December 31, 2018 $ 60 Change in fair value of the contingent consideration liability 4 Balance as of June 30, 2019 $ 64 Convertible Notes The estimated fair value of the 8.2% Convertible Senior Notes due in March 2022, which the Company issued on February 29, 2016 (see Note 7) is based on an income approach. The estimated fair value was approximately $131.9 million (par value $100.0 million) as of June 30, 2019 and represents a Level 3 valuation. When determining the estimated fair value of the Company’s long-term debt, the Company uses a single factor binomial lattice model, which incorporates the terms and conditions of the convertible notes and market based risk measurement that are indirectly observable, such as credit risk. The lattice model produces an estimated fair value based on changes in the price of the underlying common shares price over successive periods of time. An estimated yield based on market data is used to discount straight debt cash flows. |
Inventory
Inventory | 6 Months Ended |
Jun. 30, 2019 | |
Inventory Disclosure [Abstract] | |
Inventory | 4. Inventory The Company began capitalizing inventory in November 2018 upon the FDA approval of UDENYCA ® June 30, December 31, 2019 2018 Raw Materials $ 3,911 $ 2,851 Work in process 15,587 1,576 Finished goods 3,300 1,244 Total $ 22,798 $ 5,671 Balance sheet classifications (in thousand): June 30, December 31, 2019 2018 Inventory $ 4,333 $ 1,659 Inventory, non-current 18,465 4,012 Total $ 22,798 $ 5,671 Inventory expected to be sold in periods more than twelve months from the balance sheet date is classified as inventory, non-current on the balance sheet. As of June 30, 2019, the non-current portion of inventory consisted of raw materials, work in process and a portion of the finished goods. As of December 31, 2018, the non-current portion of inventory consisted of raw materials and a portion of work in process. Prepaid manufacturing of $6.3 million and $6.6 million on the condensed consolidated balance sheet as of June 30, 2019 and December 31, 2018, respectively, includes a prepayment made to a contract manufacturing organization (“CMO”) for manufacturing services and raw materials, which the Company expects to be converted into inventory within the next twelve months. |
Balance Sheet Components
Balance Sheet Components | 6 Months Ended |
Jun. 30, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Balance Sheet Components | 5 . Balance Sheet Components Property and Equipment, Net Property and equipment, net are as follows (in thousands): June 30, December 31, 2019 2018 Machinery and equipment $ 11,676 $ 11,505 Computer equipment and software 2,880 1,651 Furniture and fixtures 714 714 Leasehold improvements 4,364 4,364 Construction in progress 414 1,463 Total property and equipment 20,048 19,697 Accumulated depreciation and amortization (14,402 ) (13,037 ) Property and equipment, net $ 5,646 $ 6,660 Depreciation and amortization expense was $674,000 and $902,000 for the three months ended June 30, 2019 and 2018, respectively, and $1.4 million and $1.8 million for the six months ended June 30, 2019 and 2018, respectively. Accrued Liabilities Accrued liabilities are as follows (in thousands): June 30, December 31, 2019 2018 Accrued clinical and manufacturing $ 4,884 $ 3,950 Accrued other 3,411 3,058 Accrued liabilities $ 8,295 $ 7,008 |
Revenue
Revenue | 6 Months Ended |
Jun. 30, 2019 | |
Revenue From Contract With Customer [Abstract] | |
Revenue | 6 . Revenue The Company initiated U.S. sales of UDENYCA ® Revenue by significant Customer was distributed as follows: Three Months Ended Six Months Ended June 30, 2019 June 30, 2019 Percent of Total Percent of Total McKesson 42 % 43 % AmeriSource-Bergen Corp 31 % 32 % Cardinal 25 % 23 % Others 2 % 2 % Total revenue 100 % 100 % Product Sales Discounts and Allowances The activities and ending reserve balances for each significant category of discounts and allowances, which constitute variable consideration, were as follows (in thousands): Chargebacks Other Fees, and Discounts Co-pay for Prompt Assistance Payment Rebates and Returns Total Balance at December 31, 2018 $ — $ — $ — $ — Activity related to 2019 sales 65,726 8,593 22,843 97,162 Payments and customer credits issued (42,368 ) (1,095 ) (9,692 ) (53,155 ) Balance at June 30, 2019 $ 23,358 $ 7,498 $ 13,151 $ 44,007 Chargebacks and discounts for prompt payment are recorded as a reduction of trade receivables, and the remaining reserve balances are classified as current liabilities in the accompanying condensed consolidated balance sheets except for the co-pay assistance, which is reflected as a net prepayment in other prepaid assets on the condensed consolidated balance sheets. |
Convertible Notes and Term Loan
Convertible Notes and Term Loan | 6 Months Ended |
Jun. 30, 2019 | |
Debt Disclosure [Abstract] | |
Convertible Notes and Term Loan | 7 . Convertible Notes and Term Loan Convertible Notes On February 29, 2016, the Company issued and sold $100.0 million aggregate principal amount of its 8.2% Convertible Senior Notes (the “Convertible Notes”). The Convertible Notes constitute general, senior unsubordinated obligations of the Company and are guaranteed by certain subsidiaries of the Company. The Convertible Notes bear interest at a fixed coupon rate of 8.2% per annum payable quarterly in arrears on March 31, June 30, September 30 and December 31 of each year, which commenced on March 31, 2016, and mature on March 31, 2022, unless earlier converted, redeemed or repurchased. The Convertible Notes also bear a premium of 9% of their principal amount, which is payable when the Convertible Notes mature or are repurchased or redeemed by the Company. The Convertible Notes were issued to Healthcare Royalty Partners III, L.P., for $75.0 million in aggregate principal amount, and to three related party investors, KKR Biosimilar L.P., MX II Associates LLC, and KMG Capital Partners, LLC, for $20.0 million, $4.0 million, and $1.0 million, respectively, in aggregate principal amount. The Convertible Notes are convertible at the option of the holder at any time prior to the close of business on the business day immediately preceding March 31, 2022 at the initial conversion rate of 44.7387 shares of common stock per $1,000 principal amount of Convertible Notes, which is equivalent to an initial conversion price of approximately $22.35 per share, and is subject to adjustment in certain events. Upon conversion of the Convertible Notes by a holder, the holder will receive shares of the Company’s common stock together, if applicable, with cash in lieu of any fractional share. The Convertible Notes are redeemable in whole, and not in part, at the Company’s option on or after March 31, 2020, if the last reported sale price per share of common stock exceeds 160% of the conversion price on 20 or more trading days during the 30 consecutive trading days preceding the date on which the Company sends notice of such redemption to the holders of the Convertible Notes. At maturity or redemption, if not earlier converted, the Company will pay 109% of the principal amount of the Convertible Notes maturing or being redeemed, together with accrued and unpaid interest, in cash. The Convertible Notes contain customary negative covenants and events of default (as defined in the Convertible Note purchase agreement), the occurrence of which could result in the acceleration of all amounts due under the Convertible Note. As of June 30, 2019, the Company was in full compliance with these covenants and there were no events of default under the Convertible Notes. The Convertible Notes are accounted for in accordance with ASC Subtopic 470-20, Debt with Conversion and Other Options The following table summarizes information about the components of the Convertible Notes (in thousands): June 30, December 31, 2019 2018 Principal amount of the Convertible Notes $ 81,750 $ 81,750 Unamortized debt discount and debt issuance costs (3,834 ) (4,431 ) Convertible Notes $ 77,916 $ 77,319 Principal amount of the Convertible Notes - related parties $ 27,250 $ 27,250 Unamortized debt discount and debt issuance costs - related parties (1,278 ) (1,477 ) Convertible Notes - related parties $ 25,972 $ 25,773 Total Convertible Notes $ 103,888 $ 103,092 If the Convertible Notes were to be converted on June 30, 2019, the holders of the Convertible Notes would receive common shares with an aggregate value of $98.9 million based on the Company’s closing stock price of $22.10. The following table presents the components of interest expense (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Stated coupon interest $ 1,538 $ 1,538 $ 3,075 $ 3,075 Accretion of debt discount and debt issuance costs 302 275 597 544 Interest expense $ 1,840 $ 1,813 $ 3,672 $ 3,619 Stated coupon interest - related parties $ 512 $ 512 $ 1,025 $ 1,025 Accretion of debt discount and debt issuance costs - related parties 101 92 199 181 Interest expense - related parties $ 613 $ 604 $ 1,224 $ 1,206 Total interest expense $ 2,453 $ 2,417 $ 4,896 $ 4,825 The remaining unamortized debt discount and debt offering costs related to the Company’s Convertible Notes of approximately $5.1 million as of June 30, 2019, will be amortized using the effective interest rate over the remaining term of the Convertible Notes of 2.75 years. The annual effective interest rate is 9.48% for the Convertible Notes. The Company recognized total interest expense of $2.5 million and $2.4 million for the three months ended June 30, 2019 and 2018, respectively, and $4.9 million and $4.8 million for the six month periods ended June 30, 2019 and 2018, respectively, related to the Convertible Notes’ accrued interest and amortization of the debt discount. Future payments on the Convertible Notes as of June 30, 2019 are as follows (in thousands): Year ending December 31, Remainder of 2019 $ 4,100 2020 8,200 2021 8,200 2022 111,050 Total minimum payments 131,550 Less amount representing interest (22,550 ) Convertible Notes, principal amount 109,000 Less debt discount and debt issuance costs on Convertible Notes (5,112 ) Net carrying amount of Convertible Notes $ 103,888 Term Loan On January 7, 2019 (“the “Term Loan Closing Date”), the Company entered into a credit agreement (the “Term Loan”) with affiliates of Healthcare Royalty Partners (together, the “Lender”). The Term Loan consists of a six-year term loan facility for an aggregate principal amount of $75.0 million (the “Borrowings”). The obligations of the Company under the loan documents are guaranteed by the Company’s material domestic U.S. subsidiaries. The Borrowings under the Term Loan bear interest through maturity at 7.00% per annum plus three month LIBOR (“LIBOR”). If the consolidated net sales for UDENYCA ® The Company is required to pay principal on the Borrowings in equal quarterly installments beginning on the four year anniversary of the Term Loan Closing Date (or, if consolidated net sales of UDENYCA ® The Company is also required to make mandatory prepayments of the Borrowings under the Term Loan, subject to specified exceptions, with the proceeds of asset sales, extraordinary receipts, debt issuances and specified other events including the occurrence of a change in control. If all or any of the Borrowings are prepaid or required to be prepaid under the Term Loan, then the Company shall pay, in addition to such prepayment, a prepayment premium equal to (i) with respect to any prepayment paid or required to be paid on or prior to the three year anniversary of the Credit Agreement Closing Date, 5.00% of the Borrowings prepaid or required to be prepaid, plus all required interest payments that would have been due on the Borrowings prepaid or required to be prepaid through and including the three year anniversary of the Term Loan Closing Date, (ii) with respect to any prepayment paid or required to be paid after the three year anniversary of the Term Loan Closing Date but on or prior to the four year anniversary of the Term Loan Closing Date, 5.00% of the Borrowings prepaid or required to be prepaid, (iii) with respect to any prepayment paid or required to be paid after the four year anniversary of the Term Loan Closing Date but on or prior to the five year anniversary of the Term Loan Closing Date, 2.50% of the Borrowings prepaid or required to be prepaid, and (iv) with respect to any prepayment paid or required to be prepaid thereafter, 1.25% of the Borrowings prepaid or required to be prepaid. In connection with the Term Loan, the Company paid a fee to the Lender of approximately $1.1 million at closing in the form of an original issue discount. Upon the prepayment or maturity of the Borrowings (or upon the date such prepayment or repayment is required to be paid), it is required to pay an additional exit fee in an amount equal to 4.00% of the total principal amount of the Borrowings. The obligations under the Term Loan are secured by a lien on substantially all of the Company’s and its Guarantors’ tangible and intangible property, including intellectual property. The Term Loan contains certain affirmative covenants, negative covenants and events of default, including, covenants and restrictions that among other things, restrict the ability of the Company and its subsidiaries to, incur liens, incur additional indebtedness, make loans and investments, engage in mergers and acquisitions, in asset sales, and declare dividends or redeem or repurchase capital stock. Additionally, the consolidated net sales for UDENYCA ® The following table summarizes information about the components of the Term Loan (in thousands): June 30, 2019 Principal amount of the Term Loan $ 75,000 Unamortized debt discount and debt issuance costs (1,714 ) Term Loan $ 73,286 The following table presents the components of interest expense (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2019 2019 Stated coupon interest $ 1,801 $ 3,421 Accretion of debt discount and debt issuance costs 179 332 Interest expense $ 1,980 $ 3,753 The remaining unamortized debt discount and debt offering costs related to the Term Loan of approximately $4.7 million as of June 30, 2019, will be amortized using the effective rate over the remaining term of the Term Loan of 5.5 years. During the three and six months ended June 30, 2019, the Company recognized total interest expense of $2.0 million and $3.8 million, respectively, related to the Term Loan’s accrued interest and amortization of the debt discount. Future payments on the Term Loan as of June 30, 2019 are as follows (in thousands): Year ending December 31, Remainder of 2019 $ 3,641 2020 7,244 2021 7,224 2022 7,224 2023 39,346 2024 and beyond 47,495 Total minimum payments 112,174 Less amount representing interest (34,174 ) Term Loan, gross 78,000 Less debt discount and debt issuance costs on Term Loan (4,714 ) Net carrying amount of Term Loan $ 73,286 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 8 . Commitments and Contingencies Purchase Commitments The Company entered into agreements with a vendor and a CMO for the supplies of raw materials and manufacturing of commercial supply of UDENYCA ® Years ending December 31, Remainder of 2019 $ 9,845 2020 24,975 2021 600 2022 600 Total obligations $ 36,020 The Company enters into contracts in the normal course of business with contract research organizations for preclinical studies and clinical trials and contract manufacturing organizations for the manufacture of clinical trial materials. The contracts are cancellable, with varying provisions regarding termination. If a contract with a specific vendor were to be terminated, the Company would only be obligated for products or services that the Company had received as of the effective date of the termination and any applicable cancellation fees. Contingencies On March 3, 2017, Amgen Inc. and Amgen USA Inc. (collectively “Amgen”) filed an action against the Company, KBI BioPharma Inc., the Company’s employee Howard S. Weiser and Does 1-20 in the Superior Court of the State of California, County of Ventura. The complaint alleges that the Company engaged in unfair competition and improperly solicited and hired certain former Amgen employees in order to acquire and access trade secrets and other confidential information belonging to Amgen. On June 1, 2017, Amgen filed a Second Amended Complaint, which alleges as to Coherus (i) unfair competition under California Business and Professions Code Section 17200 et seq., (ii) misappropriation of trade secrets, (iii) aiding and abetting breach of duty of loyalty and (iv) tortious interference with contract. As to defendant Weiser, the Second Amended Complaint alleges (i) unfair competition under California Business and Professions Code Section 17200 et seq., (ii) misappropriation of trade secrets, (iii) breach of contract, (iv) violation of Penal Code Section 502 and (v) breach of duty of loyalty. KBI BioPharma Inc. is not named as a defendant in the Second Amended Complaint. The Second Amended Complaint seeks injunctive relief and monetary damages. Although Amgen has indicated it intends to seek a preliminary injunction, no motion has been filed yet. The court has set a trial date of April 22, 2019. On May 2, 2019, the Company and Amgen settled the trade secret action brought by Amgen. The details of the settlement are confidential but the Company will continue to market UDENYCA ® Guarantees and Indemnifications In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnifications. The Company’s exposure under these agreements is unknown because it involves claims that may be made against the Company in the future, but have not yet been made. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. However, the Company may record charges in the future as a result of these indemnification obligations. The Company would assess the likelihood of any adverse judgments or related claims, as well as ranges of probable losses. In the cases where the Company believes that a reasonably possible or probable loss exists, it will disclose the facts and circumstances of the claims, including an estimate range, if possible. |
Leases
Leases | 6 Months Ended |
Jun. 30, 2019 | |
Leases [Abstract] | |
Leases | 9. Leases In July 2015 , the Company entered into the office lease space for its corporate headquarters in Redwood City, California under operating lease agreement, which has been subject to an amendment to secure additional space such that the total headquarters lease space is approximately 40,341 square feet. The lease agreement, as amended, provided for aggregate tenant improvement allowance of $1.4 million, which was amortized as a reduction to rent expense on a straight-line basis over the lease term prior to the adoption of Topic 842 (see Note 2). Additionally, the lease agreement, as amended, provides for certain limited rent abatement and contains annual scheduled rent increases over the lease term. The lease terminates in November 2022 and contains a one-time option to extend the lease term for five years. As part of the lease agreement, the Company obtained a standby letter of credit (the “Letter of Credit”) in an amount of approximately $0.8 million, which may be drawn down by the landlord to be applied for certain purposes upon the Company’s breach of any provisions under of the lease. The Company will be entitled to periodically reduce the amount of the Letter of Credit during the lease term. The Letter of Credit of $0.8 million is recorded as restricted cash, non-current within the consolidated balance sheet at June 30, 2019 and December 31, 2018. The Company also leases laboratory facilities in Camarillo, California under an operating lease agreement, which has been subject to several amendments necessary to secure additional space and extend the lease term to June 30, 2020, and December 31, 2020 on the two facility structures. Effective upon the adoption of Topic 842, the Company evaluated the above facility leases and determined that they were all operating leases. In determining the present value of the lease payments, the Company used the incremental borrowing rate based on the information available at the adoption date. The lease option to extend the lease term for five years was not included as part of the right-of-use asset or lease liability as the Company was not reasonably certain it would exercise this option. The Company also performed an evaluation of its other contracts with Customers and suppliers in accordance with Topic 842 and determined that, except for the facility leases described above, none of its contracts contain a lease. The balance sheet classification of the lease liabilities was as follows (in thousands): June 30, 2019 Operating lease liabilities Other liabilities $ 2,198 Lease liabilities, non-current 5,977 Total operating lease liabilities $ 8,175 Operating lease costs were $0.5 million and $1.1 million for the three and six months ended June 30, 2019, respectively. Cash paid for amounts included in the measurement of the lease liabilities for the three and six months ended June 30, 2019 was $0.7 million and $1.3 million, respectively, and was included in net cash used in operating activities in the condensed consolidated statements of cash flows. As of June 30, 2019, the maturities of the operating lease liabilities were as follows (in thousands): Operating leases Years ending December 31, Remainder of 2019 $ 1,333 2020 2,695 2021 2,672 2022 2,518 Total lease payments 9,218 Less imputed interest (1,043 ) Operating lease liabilities $ 8,175 As of June 30, 2019, the weighted average remaining lease term was 3.4 years and the weighted average operating discount rate used to determine the operating lease liabilities was 7.0%. |
Common Stock and Stock-Based Co
Common Stock and Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Common Stock and Stock-Based Compensation | 10 . Common Stock and Stock-Based Compensation Common Stock Offerings On October 28, 2016, the Company entered into a sales agreement (the “Sales Agreement”) with Cowen to sell shares of the Company’s common stock, with aggregate gross sales proceeds of up to $100,000,000, from time to time, through an at-the-market equity offering program under which Cowen will act as its sales agent (the “ATM Offering Program”). Cowen is entitled to compensation for its services equal to 3.0% of the gross proceeds of any shares of common stock sold through Cowen under the Sales Agreement. In the first quarter of 2019, the Company sold 761,130 shares of common stock at a weighted average price of $11.17 per share through its ATM Offering Program and received total gross proceeds of $8.5 million. After deducting commission and offering expenses of $0.3 million, the net proceeds were $8.2 million. As of January 19, 2019, the Company’s Shelf Registration Statement expired and accordingly the ATM Offering Program was terminated. Stock-Based Compensation The stock-based compensation expense recorded related to options and restricted stock units granted to employees and nonemployees were as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Research and development $ 2,963 $ 4,072 $ 6,622 $ 7,835 Selling, general and administrative 5,028 4,618 10,864 9,575 $ 7,991 $ 8,690 $ 17,486 $ 17,410 Stock-based compensation of $0.5 million and $0 was capitalized into inventory for the three months ended June 30, 2019, and 2018, respectively, and $0.8 million and $0 for the six months ended June 30, 2019 and 2018, respectively. Stock-based compensation capitalized into inventory is recognized as cost of goods sold when the related product is sold. |
Net Income (Loss) Per Share Att
Net Income (Loss) Per Share Attributable to Coherus | 6 Months Ended |
Jun. 30, 2019 | |
Earnings Per Share [Abstract] | |
Net Income (Loss) Per Share Attributable to Coherus | 11. Net Income (Loss) Per Share Attributable to Coherus The following table sets forth the computation of the basic and diluted net income (loss) per share attributable to the Company (in thousands, except share and per share data): Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Basic net income (loss) per share Numerator: Net income (loss) attributable to Coherus $ 23,567 $ (43,638 ) $ 3,563 $ (87,935 ) Denominator: Weighted-average common shares outstanding 69,479,016 63,960,567 69,310,791 62,051,912 Basic net income (loss) per share attributable to Coherus $ 0.34 $ (0.68 ) $ 0.05 $ (1.42 ) Diluted net income (loss) per share Numerator: Net income (loss) attributable to Coherus $ 23,567 $ (43,638 ) $ 3,563 $ (87,935 ) Denominator: Denominator for basic net income (loss) per share attributable to Coherus 69,479,016 63,960,567 69,310,791 62,051,912 Add effect of potential dilutive securities: Stock options 3,469,172 — 2,953,049 — Restricted stock units 15,784 — 17,724 — Denominator for diluted net income (loss) per share attributable to Coherus 72,963,972 63,960,567 72,281,564 62,051,912 Diluted net income (loss) per share attributable to Coherus $ 0.32 $ (0.68 ) $ 0.05 $ (1.42 ) The following outstanding dilutive potential shares have been excluded from the calculation of diluted net income (loss) per share attributable to Coherus due to their anti-dilutive effect: Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Stock options, including purchases from contributions to ESPP 10,341,798 13,901,836 10,195,378 13,901,836 Restricted stock units - 115,064 115,064 Shares issuable upon conversion of Convertible Notes 4,473,871 4,473,871 4,473,871 4,473,871 Total 14,815,669 18,490,771 14,669,249 18,490,771 |
Related Party Transactions
Related Party Transactions | 6 Months Ended |
Jun. 30, 2019 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 12 . Related Party Transactions Transactions Associated with Medpace Agreement A prior member of the Company’s board of directors is also the president and chief executive officer of Medpace. As such, Medpace was deemed to be a related party until the director’s resignation on March 1, 2018. As a result, the Company no longer reflects balances and transactions associated with Medpace as related party in its consolidated financial statements as of March 31, 2018. The Company recognized $0 and $1.5 million during the three and six months ended June 30, 2018, respectively, for services rendered by Medpace within research and development expense in the condensed consolidated statements of operations. Recruiting Services One member of the Company’s board of directors is a partner of a firm that provides recruiting services to the Company. As such, the recruiting services provided were deemed to be related party transactions. As of June 30, 2019, and December 31, 2018, the Company had $50,000 and $0 in accounts payable - related parties reflected on its condensed consolidated balance sheet, respectively. The Company recorded in research and development in its condensed consolidated statement of operations $50,000 for both the three and six months ended June 30, 2019, and $0 for both the three and six months ended June 30, 2018. The Company recorded in selling, general and administrative in its condensed consolidated statement of operations $1,000 for both the three and six months ended June 30, 2019, and $60,000 and $100,000 for the three and six months ended June 30, 2018, respectively. Convertible Notes In February 2016, the Company issued Convertible Notes to certain related parties (some companies affiliated with members of the Company’s board of directors), for an aggregate principal amount of $25.0 million (see Note 7 for related party disclosure). |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
Unaudited Condensed Consolidated Financial Statements | Unaudited Condensed Consolidated Financial Statements The accompanying condensed consolidated financial statements include the accounts of Coherus and its wholly-owned subsidiaries as of June 30, 2019: Coherus Intermediate Corp, InteKrin Therapeutics Inc. (“InteKrin”), and InteKrin’s wholly-owned subsidiary, InteKrin Russia. Unless otherwise specified, references to the Company are references to Coherus and its consolidated subsidiaries. All intercompany transactions and balances have been eliminated upon consolidation. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the Securities Act of 1933, as amended (the “Securities Act”). Accordingly, they do not include all of the information and notes required by U.S. GAAP for complete financial statements. These unaudited condensed consolidated financial statements include all adjustments, consisting only of normal recurring accruals that the Company believes are necessary to fairly state the financial position and the results of the Company’s operations and cash flows for interim periods in accordance with U.S. GAAP. Interim-period results are not necessarily indicative of results of operations or cash flows for a full year or any subsequent interim period. The accompanying condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K filed with the SEC on February 28, 2019. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make judgements, estimates and assumptions that affect the reported amounts of assets, liabilities, equity, revenue and expenses, and related disclosures. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ from these estimates. |
Foreign Currency | Foreign Currency The functional currency of InteKrin Russia, which the Company acquired in February 2014, is the Russian Ruble. Accordingly, the financial statements of this subsidiary are translated into U.S. dollars using appropriate exchange rates. Unrealized gains or losses on translation are recognized in accumulated other comprehensive loss in the condensed consolidated balance sheet. The foreign exchange gains and losses recorded in other income, net in the condensed consolidated statements of operations for the three months ended June 30, 2019 and 2018, were a net gain of $61,000 and a net loss of $270,000, respectively, and for the six months ended June 30, 2019 and 2018 were a net gain of $230,000 and a net loss of $278,000, respectively. |
Segment Reporting | Segment Reporting The Company operates and manages its business as one reportable and operating segment, which is the business of developing and commercializing biosimilar products, and, as part of the InteKrin acquisition, small molecules. The Company’s chief executive officer, who is the chief operating decision maker, reviews financial information on an aggregate basis for purposes of allocating resources and evaluating financial performance. Long-lived assets are primarily maintained in the United States of America. See Note 6 for disclosures about product sales and revenue from major customers. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash Cash, cash equivalents and restricted cash is comprised of cash and highly liquid investments with remaining maturities of 90 days or less at the date of purchase. The Company limits cash investments to financial institutions with high credit standings; therefore, management believes that there is no significant exposure to any credit risk in the Company’s cash, cash equivalents and restricted cash. The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets and which, in aggregate, represent the amount reported in the condensed consolidated statements of cash flows. June 30, June 30, 2019 2018 Cash and cash equivalents $ 105,927 $ 130,005 Restricted cash 50 50 Restricted cash - non-current 785 785 Total cash, cash equivalents and restricted cash $ 106,762 $ 130,840 Restricted cash consists of cash held in money market accounts at banks. The restricted cash is used as collateral against the Company’s corporate credit cards and is classified as current; restricted cash – non-current is held to cover the standby letter of credit issued by the Company’s landlord to drawdown on in the event the facility lease is breached. |
Trade Receivables | Trade Receivables Trade receivables are recorded net of allowances for chargebacks and cash discounts for prompt payment. The Company’s estimate of the allowance for doubtful accounts is based on an evaluation of the aging of its receivables. Trade receivable balances are written off against the allowance when it is probable that the receivable will not be collected. To date, the Company has determined that an allowance for doubtful accounts is not required. |
Investments in Marketable Securities | Investments in Marketable Securities Management determines the appropriate classification of investments in marketable securities at the time of purchase based upon management’s intent with regards to such investments and reevaluates such designation as of each balance sheet date. All investments in marketable securities are held as “available-for-sale” and are carried at the estimated fair value as determined based upon quoted market prices or pricing models for similar securities. The Company classifies investments in marketable securities as short-term when they have remaining contractual maturities of one year or less from the balance sheet date. Unrealized gains and losses are excluded from earnings and are reported as a component of accumulated comprehensive income (loss). Realized gains and losses and declines in value judged to be other than temporary, if any, on available-for-sale securities are included in other income, net, based on the specific identification method. |
Inventory | Inventory Prior to the regulatory approval of its product candidates, the Company incurred expenses for the manufacture of drug products that could potentially be available to support the commercial launch of its products. The Company began to capitalize inventory costs associated with UDENYCA ® ® Inventory is stated at the lower of cost or estimated net realizable value with cost determined under the first-in first-out method. Inventory costs include third-party contract manufacturing, third-party packaging services, freight, labor costs for personnel involved in the manufacturing process and indirect overhead costs. The Company primarily uses actual costs to determine the cost basis for inventory. The determination of whether inventory costs will be realizable requires management review of the expiration dates of UDENYCA ® |
Leases | Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use assets, other liabilities, and lease liabilities, non-current in the condensed consolidated balance sheets. Right-of-use assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. In determining the present value of lease payments, the Company uses the incremental borrowing rate based on the information available at the lease commencement date. Lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise any such options. Lease expense is recognized on a straight-line basis over the expected lease term. |
Revenue Recognition | Revenue Recognition The Company adopted ASU 2014-09, Revenue from Contracts with Customers (Topic 606), ASU 2014-09: ASU No. 2016-08, Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations ; ASU No. 2016-10, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing ; and ASU No. 2016-12, Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients , (collectively, the “New Revenue Standard”) on January 1, 2018 using the modified retrospective method. Topic 606 supersedes all previous revenue recognition requirements in accordance with generally accepted accounting principles. This standard applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. Under Topic 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration to which the entity is entitled to in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines is within the scope of Topic 606, it performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the performance obligation is satisfied. The Company only applies the five-step model to contracts when it is probable that it will collect the consideration it is entitled to in exchange for the goods or services it transferred to the customer. Net Product Revenue The Company sells UDENYCA ® ® ® ® to Healthcare Providers ® Product Sales Discounts and Allowances Revenues from product sales are recorded at the net sales price (“transaction price”), which includes estimates of variable consideration for which reserves are established and that result from chargebacks, rebates, co-pay assistance, prompt-payment discounts, returns and other allowances that are offered within contracts between the Company and its Customers, Healthcare Providers, payers and GPOs relating to the sales of UDENYCA ® Chargebacks: Chargebacks are discounts that occur when Healthcare Providers purchase directly from a Customer. Healthcare Providers, which belong to Public Health Service institutions, non-profit clinics, government entities, GPOs, and health maintenance organizations, generally purchase the product at a discounted price. The Customer, in turn, charges back to the Company the difference between the price initially paid by the Customer and the discounted price paid by the Healthcare Providers to the Customer. The allowance for chargebacks is based on an estimate of sales through to Healthcare Providers from the Customer. Discounts for Prompt Payment: The Company provides for prompt payment discounts to its Customers, which are recorded as a reduction in revenue in the same period that the related product revenue is recognized. Rebates: Rebates include mandated discounts under the Medicaid Drug Rebate Program, other government programs and commercial contracts. Rebate amounts owed after the final dispensing of the product to a benefit plan participant are based upon contractual agreements or legal requirements with these public sector benefit providers. Certain rebate amounts commensurate with share utilization of UDENYCA relative to other pegfilgrastim products. The accrual for rebates is based on statutory or contractual discount rates and expected utilization. The estimates for the expected utilization of rebates are based on Customer and commercially available payer data, as well as data collected from the Healthcare Providers, Customers, GPOs, and historical utilization rates. Rebates invoiced by payers, Healthcare Providers and GPOs are paid in arrears. If actual future rebates vary from estimates, the Company may need to adjust its accruals, which would affect net product revenue in the period of adjustment. Co-payment Assistance: Patients who have commercial insurance and meet certain eligibility requirements may receive co-payment assistance. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue. Product Returns: The Company offer to its Customers limited product return right, which is principally based upon damaged, defective or the product’s expiration date. Product return allowance is estimated and recorded at the time of sale. Other Allowances: The Company pays fees to Customers and GPOs for account management, data management and other administrative services. To the extent that the services received are distinct from the sale of products to the customer, these payments are classified in selling, general and administrative expense in the Company’s condensed consolidated statements of operations, otherwise they are included as a reduction to product revenue. |
Cost of Goods Sold | Cost of Goods Sold Cost of goods sold consists primarily of third-party manufacturing, distribution, and overhead costs associated with UDENYCA ® ® ® On May 2, 2019, the Company and Amgen settled a trade secret action brought by Amgen. The Company will pay a mid-single digit royalty on net product revenue to Amgen beginning on July 1, 2019 for five years. Cost of goods sold for the six months ended June 30, 2019, included write-off of prepaid manufacturing costs of $1.3 million due to the cancellation of certain manufacturing reservations, and $0.4 million due to the write-off of excess and obsolete inventory. |
Research and Development Expense | Research and Development Expense Research and development costs are charged to expense as incurred. Research and development expense includes, among other costs, salaries and other personnel-related costs, consultant fees, preclinical costs, cost to manufacture drug candidates and clinical trial costs and supplies, laboratory supplies costs and facility-related costs. Costs incurred under agreements with third parties are charged to expense as incurred in accordance with the specific contractual performance terms of such agreements. Costs of third parties include costs associated with manufacturing drug candidates, preclinical and clinical support activities. Advance payments for goods or services to be received in the future and utilized in research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are delivered or the services are received. The Company considers regulatory approval of product candidates to be uncertain, and product manufactured prior to regulatory approval may not be sold unless regulatory approval is obtained. The Company expenses manufacturing costs as incurred to research and development expense for product candidates prior to regulatory approval. If, and when, regulatory approval of a product is obtained, the Company will begin capitalizing manufacturing costs related to the approved product into inventory |
Comprehensive Income (Loss) | Comprehensive Income (Loss) Comprehensive income (loss) is composed of two components: net income (loss) and other comprehensive income (loss). Other comprehensive income (loss) refers to gains and losses that under U.S. GAAP are recorded as an element of stockholders’ equity (deficit), but are excluded from net income (loss). The Company’s other comprehensive income (loss) includes unrealized gains and losses from available-for-sale marketable securities and foreign currency translation adjustments for the six months ended June 30, 2019 and 2018. |
Net Income (Loss) per Share Attributable to Coherus | Net Income (Loss) per Share Attributable to Coherus Basic net income (loss) per share attributable to Coherus is calculated by dividing the net income (loss) attributable to Coherus by the weighted-average number of shares of common stock outstanding for the period, without consideration for potential dilutive common shares. Diluted net income (loss) per share is computed by dividing the net income (loss) per share by the weighted average number of common shares outstanding for the period plus any diluted potential common shares outstanding for the period determined using the treasury stock method for options, RSUs and ESPP and using the if-converted method for the convertible notes (see Note 11). |
Income Taxes | Income Taxes The Company uses the liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company must then assess the likelihood that the resulting deferred tax assets will be realized. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. Due to the Company’s lack of earnings history, the net deferred tax assets have been fully offset by a valuation allowance. The Company recognizes uncertain income tax positions at the largest amount that is more likely than not to be sustained upon audit by the relevant taxing authority. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being sustained. The Company does not expect its unrecognized tax benefits to change significantly over the next twelve months. The Company’s policy is to recognize interest and/or penalties related to income tax matters in income tax expense. The Company had accrued no amounts for interest and penalties related to income tax matters in the Company’s consolidated balance sheet at June 30, 2019 and December 31, 2018. For the three and six months ended June 30, 2019, the Company recorded income tax provision of $51,000, which comprised of state taxes in jurisdictions outside of California for which the Company has a limited operating history. Income tax provision during interim periods is based on applying an estimated annual effective income tax rate to year-to-date income, plus any significant unusual or infrequently occurring items which are recorded in the interim period in accordance with ASC 740-270. The income tax provision for the three months ended June 30, 2019 differs from the U.S. federal statutory rate of 21% primarily due to effect of change in the valuation allowance against the Company’s federal deferred tax assets which reduced the Company’s net tax expense. The Company maintains a full valuation allowance against its net deferred tax assets due to the Company’s history of losses as of June 30, 2019. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements The following are the recent accounting pronouncements adopted by the Company in 2019: In February 2016, the FASB issued ASU No. 2016-02, Leases Leases The impact of the adoption of Topic 842 on the accompanying condensed consolidated balance sheet as of January 1, 2019 was as follows (in thousands): December 31, 2018 Adjustments Due to the Adoption of Topic 842 January 1, 2019 Operating lease right-of-use asset $ — $ 7,172 $ 7,172 Operating lease liabilities: Other current liabilities ( 1) $ 419 $ 1,665 $ 2,084 Other lease liabilities, non-current ( 2) $ 1,645 $ 5,466 $ 7,111 ______________________________________________________ (1) Includes current portion of deferred rent and current portion of operating lease liabilities. (2) Non-current portion of deferred rent and operating lease liabilities. The impact of the adoption of Topic 842 on the accompanying condensed consolidated statement of operations as of and for the three and six months ended June 30, 2019 were as follows (in thousands): Three Months Ended June 30, 2019 Balance without As Reported Higher (Lower) the Adoption Research and development $ 18,883 $ 39 $ 18,922 Selling, general and administrative $ 36,456 $ 43 $ 36,499 Total operating expenses $ 55,940 $ 82 $ 56,022 Income from operations $ 27,493 $ (82 ) $ 27,411 Net income $ 23,567 $ (82 ) $ 23,485 Net income attributable to Coherus $ 23,567 $ (82 ) $ 23,485 Six Months Ended June 30, 2019 Balance without As Reported Higher (Lower) the Adoption Research and development $ 37,672 $ 83 $ 37,755 Selling, general and administrative $ 69,139 $ 87 $ 69,226 Total operating expenses $ 109,637 $ 170 $ 109,807 Income from operations $ 10,894 $ (170 ) $ 10,724 Net income $ 3,563 $ (170 ) $ 3,393 Net income attributable to Coherus $ 3,563 $ (170 ) $ 3,393 In June 2018, the FASB issued ASU No. 2018-07, Improvements to Nonemployee Share-Based Payment Accounting In August 2018, the SEC adopted amendments to certain disclosure requirements in Securities Act Release No. 33-10532, Disclosure Update and Simplification. January 1, 2019 and such adoption did not The following are the recent accounting pronouncements that the Company has not yet adopted: In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326) (ASU 2016-13). In January 2017, the FASB issued ASU No. 2017-04, Intangibles-Goodwill and Other: Simplifying the Test for Goodwill Impairment In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurements The Company has reviewed other recent accounting pronouncements and concluded they are either not applicable to the business or that no material effect is expected on the consolidated financial statements as a result of future adoption. |
Fair Value Measurements | Fair Value Measurements Financial assets and liabilities are recorded at fair value. The carrying amounts of certain of the Company’s financial instruments, including cash and cash equivalents, restricted cash, investments in marketable securities, accounts receivable, accounts payable and other current liabilities approximate their fair value due to their short maturities. Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The accounting guidance describes a fair value hierarchy based on three levels of inputs that may be used to measure fair value, of which the first two are considered observable and the last is considered unobservable. These levels of inputs are the following: Level 1 — Quoted prices in active markets for identical assets or liabilities. Level 2 — Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. A financial instrument’s categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. The Company’s financial instruments consist of Level 1 and Level 2 assets, and Level 3 liabilities. Where quoted prices are available in an active market, securities are classified as Level 1. Level 1 assets consist of highly liquid money market funds. When quoted market prices are not available for the specific security, then the Company estimates the fair value by using quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant inputs are observable in the market or can be corroborated by observable market data for substantially the full term of the assets. Where applicable, these models project future cash flows and discount the future amounts to a present value using market-based observable inputs obtained from various third party data providers, including but not limited to, benchmark yields, interest rate curves, reported trades, broker/dealer quotes and market reference data. Level 2 assets consist of corporate notes and commercial paper. Level 2 inputs for the valuations are limited to quoted prices for similar assets or liabilities in active markets and inputs other than quoted prices that are observable for the asset or liability. In certain cases where there is limited activity or less transparency around inputs to valuation, securities are classified as Level 3. Level 3 liabilities consist of the contingent consideration. |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | |
Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets and which, in aggregate, represent the amount reported in the condensed consolidated statements of cash flows. June 30, June 30, 2019 2018 Cash and cash equivalents $ 105,927 $ 130,005 Restricted cash 50 50 Restricted cash - non-current 785 785 Total cash, cash equivalents and restricted cash $ 106,762 $ 130,840 |
Adoption of Topic 842 | |
Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | |
Summary of Impact of Adoption of Topic 842 on Financial Statement | The impact of the adoption of Topic 842 on the accompanying condensed consolidated balance sheet as of January 1, 2019 was as follows (in thousands): December 31, 2018 Adjustments Due to the Adoption of Topic 842 January 1, 2019 Operating lease right-of-use asset $ — $ 7,172 $ 7,172 Operating lease liabilities: Other current liabilities ( 1) $ 419 $ 1,665 $ 2,084 Other lease liabilities, non-current ( 2) $ 1,645 $ 5,466 $ 7,111 ______________________________________________________ (1) Includes current portion of deferred rent and current portion of operating lease liabilities. (2) Non-current portion of deferred rent and operating lease liabilities. The impact of the adoption of Topic 842 on the accompanying condensed consolidated statement of operations as of and for the three and six months ended June 30, 2019 were as follows (in thousands): Three Months Ended June 30, 2019 Balance without As Reported Higher (Lower) the Adoption Research and development $ 18,883 $ 39 $ 18,922 Selling, general and administrative $ 36,456 $ 43 $ 36,499 Total operating expenses $ 55,940 $ 82 $ 56,022 Income from operations $ 27,493 $ (82 ) $ 27,411 Net income $ 23,567 $ (82 ) $ 23,485 Net income attributable to Coherus $ 23,567 $ (82 ) $ 23,485 Six Months Ended June 30, 2019 Balance without As Reported Higher (Lower) the Adoption Research and development $ 37,672 $ 83 $ 37,755 Selling, general and administrative $ 69,139 $ 87 $ 69,226 Total operating expenses $ 109,637 $ 170 $ 109,807 Income from operations $ 10,894 $ (170 ) $ 10,724 Net income $ 3,563 $ (170 ) $ 3,393 Net income attributable to Coherus $ 3,563 $ (170 ) $ 3,393 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Fair Value Disclosures [Abstract] | |
Financial Assets and Liabilities Measured on a Recurring Basis | Financial assets and liabilities subject to fair value measurements on a recurring basis and the level of inputs used in such measurements are as follows (in thousands): Fair Value Measurements June 30, 2019 Total Level 1 Level 2 Level 3 Financial Assets: Money market funds $ 83,326 $ 83,326 $ — $ — Restricted cash (money market funds) 835 835 — — Corporate notes and commercial paper 12,573 — 12,573 — Total financial assets $ 96,734 $ 84,161 $ 12,573 $ — Financial Liabilities: Contingent consideration $ 64 $ — $ — $ 64 Fair Value Measurements December 31, 2018 Total Level 1 Level 2 Level 3 Financial Assets: Money market funds $ 71,062 $ 71,062 $ — $ — Restricted cash (money market funds) 835 835 — — Total financial assets $ 71,897 $ 71,897 $ — $ — Financial Liabilities: Contingent consideration $ 60 $ — $ — $ 60 |
Schedule of Cash Equivalents, Investments in Marketable Securities Classified as Available-for-Sale Securities and Restricted Cash | Cash equivalents, investments in marketable securities, which are classified as available-for-sale securities, and restricted cash, consisted of the following (in thousands): June 30, 2019 Cost Unrealized Gain Unrealized (Loss) Estimated Fair Value Money market funds $ 83,326 $ — $ — $ 83,326 Corporate notes and commercial paper 6,582 — — 6,582 Classified as cash equivalents $ 89,908 $ — $ — $ 89,908 Corporate notes and commercial paper $ 5,991 $ — $ — $ 5,991 Classified as investments in marketable securities $ 5,991 $ — $ — $ 5,991 Restricted cash (money market funds) $ 835 $ — $ — $ 835 Classified as restricted cash $ 835 $ — $ — $ 835 December 31, 2018 Cost Unrealized Gain Unrealized (Loss) Estimated Fair Value Money market funds $ 71,062 $ — $ — $ 71,062 Classified as cash equivalents $ 71,062 $ — $ — $ 71,062 Restricted cash (money market funds) $ 835 $ — $ — $ 835 Classified as restricted cash $ 835 $ — $ — $ 835 |
Summary of Changes in the Estimated Fair Value of Contingent Consideration | The following table sets forth a summary of changes in the estimated fair value of the contingent consideration (in thousands): Balance as of December 31, 2018 $ 60 Change in fair value of the contingent consideration liability 4 Balance as of June 30, 2019 $ 64 |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | The Company began capitalizing inventory in November 2018 upon the FDA approval of UDENYCA ® June 30, December 31, 2019 2018 Raw Materials $ 3,911 $ 2,851 Work in process 15,587 1,576 Finished goods 3,300 1,244 Total $ 22,798 $ 5,671 |
Schedule of Balance Sheet Classification | Balance sheet classifications (in thousand): June 30, December 31, 2019 2018 Inventory $ 4,333 $ 1,659 Inventory, non-current 18,465 4,012 Total $ 22,798 $ 5,671 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Schedule of Property and Equipment, Net | Property and equipment, net are as follows (in thousands): June 30, December 31, 2019 2018 Machinery and equipment $ 11,676 $ 11,505 Computer equipment and software 2,880 1,651 Furniture and fixtures 714 714 Leasehold improvements 4,364 4,364 Construction in progress 414 1,463 Total property and equipment 20,048 19,697 Accumulated depreciation and amortization (14,402 ) (13,037 ) Property and equipment, net $ 5,646 $ 6,660 |
Schedule of Accrued Liabilities | Accrued liabilities are as follows (in thousands): June 30, December 31, 2019 2018 Accrued clinical and manufacturing $ 4,884 $ 3,950 Accrued other 3,411 3,058 Accrued liabilities $ 8,295 $ 7,008 |
Revenue (Tables)
Revenue (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Revenue From Contract With Customer [Abstract] | |
Revenue by Significant Customer | Revenue by significant Customer was distributed as follows: Three Months Ended Six Months Ended June 30, 2019 June 30, 2019 Percent of Total Percent of Total McKesson 42 % 43 % AmeriSource-Bergen Corp 31 % 32 % Cardinal 25 % 23 % Others 2 % 2 % Total revenue 100 % 100 % |
Activities and Ending Reserve Balances for Each Significant Category of Discounts and Allowances | The activities and ending reserve balances for each significant category of discounts and allowances, which constitute variable consideration, were as follows (in thousands): Chargebacks Other Fees, and Discounts Co-pay for Prompt Assistance Payment Rebates and Returns Total Balance at December 31, 2018 $ — $ — $ — $ — Activity related to 2019 sales 65,726 8,593 22,843 97,162 Payments and customer credits issued (42,368 ) (1,095 ) (9,692 ) (53,155 ) Balance at June 30, 2019 $ 23,358 $ 7,498 $ 13,151 $ 44,007 |
Convertible Notes and Term Lo_2
Convertible Notes and Term Loan (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Debt Instrument [Line Items] | |
Components of Convertible Notes | The following table summarizes information about the components of the Convertible Notes (in thousands): June 30, December 31, 2019 2018 Principal amount of the Convertible Notes $ 81,750 $ 81,750 Unamortized debt discount and debt issuance costs (3,834 ) (4,431 ) Convertible Notes $ 77,916 $ 77,319 Principal amount of the Convertible Notes - related parties $ 27,250 $ 27,250 Unamortized debt discount and debt issuance costs - related parties (1,278 ) (1,477 ) Convertible Notes - related parties $ 25,972 $ 25,773 Total Convertible Notes $ 103,888 $ 103,092 |
Components of Interest Expense | The following table presents the components of interest expense (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Stated coupon interest $ 1,538 $ 1,538 $ 3,075 $ 3,075 Accretion of debt discount and debt issuance costs 302 275 597 544 Interest expense $ 1,840 $ 1,813 $ 3,672 $ 3,619 Stated coupon interest - related parties $ 512 $ 512 $ 1,025 $ 1,025 Accretion of debt discount and debt issuance costs - related parties 101 92 199 181 Interest expense - related parties $ 613 $ 604 $ 1,224 $ 1,206 Total interest expense $ 2,453 $ 2,417 $ 4,896 $ 4,825 |
Schedule of Future Payments on Debt | Future payments on the Convertible Notes as of June 30, 2019 are as follows (in thousands): Year ending December 31, Remainder of 2019 $ 4,100 2020 8,200 2021 8,200 2022 111,050 Total minimum payments 131,550 Less amount representing interest (22,550 ) Convertible Notes, principal amount 109,000 Less debt discount and debt issuance costs on Convertible Notes (5,112 ) Net carrying amount of Convertible Notes $ 103,888 |
Term Loan | |
Debt Instrument [Line Items] | |
Components of Interest Expense | The following table presents the components of interest expense (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2019 2019 Stated coupon interest $ 1,801 $ 3,421 Accretion of debt discount and debt issuance costs 179 332 Interest expense $ 1,980 $ 3,753 |
Schedule of Future Payments on Debt | Future payments on the Term Loan as of June 30, 2019 are as follows (in thousands): Year ending December 31, Remainder of 2019 $ 3,641 2020 7,244 2021 7,224 2022 7,224 2023 39,346 2024 and beyond 47,495 Total minimum payments 112,174 Less amount representing interest (34,174 ) Term Loan, gross 78,000 Less debt discount and debt issuance costs on Term Loan (4,714 ) Net carrying amount of Term Loan $ 73,286 |
Components of Term Loan | The following table summarizes information about the components of the Term Loan (in thousands): June 30, 2019 Principal amount of the Term Loan $ 75,000 Unamortized debt discount and debt issuance costs (1,714 ) Term Loan $ 73,286 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Schedule of Contractual Obligations Under Terms of Agreements | As of June 30, 2019, the Company’s contractual obligations under the terms of the agreements were as follows (in thousands): Years ending December 31, Remainder of 2019 $ 9,845 2020 24,975 2021 600 2022 600 Total obligations $ 36,020 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Leases [Abstract] | |
Schedule of Balance Sheet Classification of Lease Liabilities | The balance sheet classification of the lease liabilities was as follows (in thousands): June 30, 2019 Operating lease liabilities Other liabilities $ 2,198 Lease liabilities, non-current 5,977 Total operating lease liabilities $ 8,175 |
Schedule of Maturities of Operating Lease Liabilities | As of June 30, 2019, the maturities of the operating lease liabilities were as follows (in thousands): Operating leases Years ending December 31, Remainder of 2019 $ 1,333 2020 2,695 2021 2,672 2022 2,518 Total lease payments 9,218 Less imputed interest (1,043 ) Operating lease liabilities $ 8,175 |
Common Stock and Stock-Based _2
Common Stock and Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Employee And Nonemployee Stock Option Restricted Stock Units | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |
Schedule of Stock-Based Compensation Expense | The stock-based compensation expense recorded related to options and restricted stock units granted to employees and nonemployees were as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Research and development $ 2,963 $ 4,072 $ 6,622 $ 7,835 Selling, general and administrative 5,028 4,618 10,864 9,575 $ 7,991 $ 8,690 $ 17,486 $ 17,410 |
Net Income (Loss) Per Share A_2
Net Income (Loss) Per Share Attributable to Coherus (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Earnings Per Share [Abstract] | |
Computation of Basic and Diluted Net Income (Loss) Per Share Attributable to the Company | The following table sets forth the computation of the basic and diluted net income (loss) per share attributable to the Company (in thousands, except share and per share data): Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Basic net income (loss) per share Numerator: Net income (loss) attributable to Coherus $ 23,567 $ (43,638 ) $ 3,563 $ (87,935 ) Denominator: Weighted-average common shares outstanding 69,479,016 63,960,567 69,310,791 62,051,912 Basic net income (loss) per share attributable to Coherus $ 0.34 $ (0.68 ) $ 0.05 $ (1.42 ) Diluted net income (loss) per share Numerator: Net income (loss) attributable to Coherus $ 23,567 $ (43,638 ) $ 3,563 $ (87,935 ) Denominator: Denominator for basic net income (loss) per share attributable to Coherus 69,479,016 63,960,567 69,310,791 62,051,912 Add effect of potential dilutive securities: Stock options 3,469,172 — 2,953,049 — Restricted stock units 15,784 — 17,724 — Denominator for diluted net income (loss) per share attributable to Coherus 72,963,972 63,960,567 72,281,564 62,051,912 Diluted net income (loss) per share attributable to Coherus $ 0.32 $ (0.68 ) $ 0.05 $ (1.42 ) |
Outstanding Dilutive Potential Shares Excluded from Calculation of Diluted Net Income (Loss) Per Share Attributable to Coherus | The following outstanding dilutive potential shares have been excluded from the calculation of diluted net income (loss) per share attributable to Coherus due to their anti-dilutive effect: Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Stock options, including purchases from contributions to ESPP 10,341,798 13,901,836 10,195,378 13,901,836 Restricted stock units - 115,064 115,064 Shares issuable upon conversion of Convertible Notes 4,473,871 4,473,871 4,473,871 4,473,871 Total 14,815,669 18,490,771 14,669,249 18,490,771 |
Organization and Operations - A
Organization and Operations - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | Jan. 07, 2019 | Jan. 31, 2019 | Jun. 30, 2019 | Dec. 31, 2018 | [1] |
Organization And Operations [Line Items] | |||||
Accumulated deficit | $ 981,268 | $ 984,831 | |||
Cash and cash equivalents and short-term investments | $ 111,900 | ||||
HRP III Member | Term Loan | |||||
Organization And Operations [Line Items] | |||||
Line of credit facility, maximum borrowing capacity | $ 75,000 | ||||
Term loan facility term | 6 years | ||||
At-the-Market Equity Offering Program | |||||
Organization And Operations [Line Items] | |||||
Common stock, shares issued and sold | 761,130 | ||||
Common stock, net proceeds | $ 8,200 | ||||
At-the-Market Equity Offering Program | Weighted Average | |||||
Organization And Operations [Line Items] | |||||
Share price | $ 11.17 | ||||
[1] | The consolidated balance sheet as of December 31, 2018 has been derived from the audited consolidated balance sheet included in the Company’s 2018 Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2019. |
Basis of Presentation and Sum_4
Basis of Presentation and Summary of Significant Accounting Policies - Additional Information (Details) | May 02, 2019 | Jun. 30, 2019USD ($) | Jun. 30, 2018USD ($) | Jun. 30, 2019USD ($)Segments | Jun. 30, 2018USD ($) | Jan. 01, 2019USD ($) | Dec. 31, 2018USD ($) | |
Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | ||||||||
Foreign exchange gain (loss) | $ 61,000 | $ (270,000) | $ 230,000 | $ (278,000) | ||||
Number of reportable segment | Segments | 1 | |||||||
Number of operating segments | Segments | 1 | |||||||
Write-off of prepaid manufacturing costs | $ 1,300,000 | |||||||
Write-off of excess and obsolete inventory | $ 400,000 | |||||||
Description of uncertain income tax position | 0 | |||||||
Accrued interest and Penalties | 0 | $ 0 | $ 0 | |||||
Income tax provision | $ 51,000 | $ 0 | 51,000 | $ 0 | ||||
U.S. federal corporate tax rate | 21.00% | |||||||
Operating lease, right-of-use asset | $ 6,353,000 | 6,353,000 | $ 7,200,000 | 0 | [1] | |||
Operating lease liability noncurrent | $ 5,977,000 | $ 5,977,000 | $ 9,200,000 | $ 0 | [1] | |||
Amgen | ||||||||
Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | ||||||||
Royalty payment term | 5 years | |||||||
[1] | The consolidated balance sheet as of December 31, 2018 has been derived from the audited consolidated balance sheet included in the Company’s 2018 Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2019. |
Basis of Presentation and Sum_5
Basis of Presentation and Summary of Significant Accounting Policies - Reconciliation of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 | Jun. 30, 2018 | Dec. 31, 2017 | |
Accounting Policies [Abstract] | |||||
Cash and cash equivalents | $ 105,927 | $ 72,356 | [1] | $ 130,005 | |
Restricted cash | 50 | 50 | [1] | 50 | |
Restricted cash, non-current | 785 | 785 | [1] | 785 | |
Total cash, cash equivalents and restricted cash | $ 106,762 | $ 73,191 | $ 130,840 | $ 127,756 | |
[1] | The consolidated balance sheet as of December 31, 2018 has been derived from the audited consolidated balance sheet included in the Company’s 2018 Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2019. |
Basis of Presentation and Sum_6
Basis of Presentation and Summary of Significant Accounting Policies - Summary of Adoption of Topic 842 In Condensed Consolidated Balance Sheet (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Jan. 01, 2019 | Dec. 31, 2018 | ||
Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | |||||
Operating lease right-of-use asset | $ 6,353 | $ 7,200 | $ 0 | [1] | |
Operating lease, liability, current | 2,198 | ||||
Operating lease liability noncurrent | $ 5,977 | 9,200 | 0 | [1] | |
Adoption of Topic 842 | |||||
Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | |||||
Operating lease right-of-use asset | 7,172 | ||||
Other current liabilities | |||||
Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | |||||
Operating lease, liability, current | [2] | 419 | |||
Other current liabilities | Adoption of Topic 842 | |||||
Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | |||||
Operating lease, liability, current | [2] | 2,084 | |||
Other lease liabilities, non-current | |||||
Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | |||||
Operating lease liability noncurrent | [3] | $ 1,645 | |||
Other lease liabilities, non-current | Adoption of Topic 842 | |||||
Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | |||||
Operating lease liability noncurrent | [3] | 7,111 | |||
Adjustments Due to the Adoption of Topic 842 | Adoption of Topic 842 | |||||
Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | |||||
Operating lease right-of-use asset | 7,172 | ||||
Adjustments Due to the Adoption of Topic 842 | Other current liabilities | Adoption of Topic 842 | |||||
Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | |||||
Operating lease, liability, current | [2] | 1,665 | |||
Adjustments Due to the Adoption of Topic 842 | Other lease liabilities, non-current | Adoption of Topic 842 | |||||
Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | |||||
Operating lease liability noncurrent | [3] | $ 5,466 | |||
[1] | The consolidated balance sheet as of December 31, 2018 has been derived from the audited consolidated balance sheet included in the Company’s 2018 Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2019. | ||||
[2] | Includes current portion of deferred rent and current portion of operating lease liabilities. | ||||
[3] | Non-current portion of deferred rent and operating lease liabilities. |
Basis of Presentation and Sum_7
Basis of Presentation and Summary of Significant Accounting Policies - Summary of Impact of Adoption of Topic 842 on Condensed Consolidated Statement of Operations (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2018 | Mar. 31, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | ||||||
Research and development | $ 18,883 | $ 26,519 | $ 37,672 | $ 51,974 | ||
Selling, general and administrative | 36,456 | 18,391 | 69,139 | 34,968 | ||
Total operating expenses | 55,940 | 44,910 | 109,637 | 86,942 | ||
Income from operations | 27,493 | (44,910) | 10,894 | (86,942) | ||
Net income | 23,567 | (43,685) | 3,563 | (87,987) | ||
Net income attributable to Coherus | 23,567 | $ (20,004) | $ (43,638) | $ (44,297) | 3,563 | $ (87,935) |
Higher (Lower) | Adoption of Topic 842 | ||||||
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | ||||||
Research and development | 39 | 83 | ||||
Selling, general and administrative | 43 | 87 | ||||
Total operating expenses | 82 | 170 | ||||
Income from operations | (82) | (170) | ||||
Net income | (82) | (170) | ||||
Net income attributable to Coherus | (82) | (170) | ||||
Balance without the Adoption of ASC 842 | Adoption of Topic 842 | ||||||
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | ||||||
Research and development | 18,922 | 37,755 | ||||
Selling, general and administrative | 36,499 | 69,226 | ||||
Total operating expenses | 56,022 | 109,807 | ||||
Income from operations | 27,411 | 10,724 | ||||
Net income | 23,485 | 3,393 | ||||
Net income attributable to Coherus | $ 23,485 | $ 3,393 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) | Feb. 29, 2016USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2018USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2018USD ($) | Dec. 31, 2018USD ($) |
Fair Value Disclosures [Line Items] | ||||||
Transfers from Level 1 to Level 3 | $ 0 | $ 0 | ||||
Transfers from Level 3 to Level 1 | 0 | $ 0 | ||||
Available-for-sale securities, gross realized gains | $ 145,000 | $ 143,000 | 257,000 | $ 226,000 | ||
Available-for-sale securities, gross realized losses | 0 | 0 | 0 | 0 | ||
Remeasurement of fair-value contingent consideration | 4,000 | (3,195,000) | ||||
8.2% Senior Convertible Notes Due March 2022 | ||||||
Fair Value Disclosures [Line Items] | ||||||
Aggregate principal amount | $ 100,000,000 | |||||
Convertible notes, interest rate | 8.20% | |||||
Debt instrument maturity date | Mar. 31, 2022 | |||||
Other Income, Net | ||||||
Fair Value Disclosures [Line Items] | ||||||
Remeasurement of fair-value contingent consideration | 0 | $ 3,400,000 | 4,000 | $ 3,200,000 | ||
Level 3 | 8.2% Senior Convertible Notes Due March 2022 | ||||||
Fair Value Disclosures [Line Items] | ||||||
Debt instrument fair value | $ 131,900,000 | $ 131,900,000 | ||||
Fair Value Measurements Recurring Basis | Level 3 | Contingent Consideration | ||||||
Fair Value Disclosures [Line Items] | ||||||
Increase (decrease) in expected probability of compound transaction payment occurrence | 1.00% | |||||
Fair Value Measurements Recurring Basis | Level 3 | Contingent Consideration | Measurement Input, Discount Rate | ||||||
Fair Value Disclosures [Line Items] | ||||||
Fair value investment measurement input | 20 | 20 | ||||
Fair Value Measurements Recurring Basis | Level 3 | Contingent Consideration | Measurement Input, Counterparty Credit Risk | ||||||
Fair Value Disclosures [Line Items] | ||||||
Fair value investment measurement input | 8 | 8 | ||||
Maximum | ||||||
Fair Value Disclosures [Line Items] | ||||||
Available sale of securities remaining contractual period | 1 year | 1 year |
Fair Value Measurements - Finan
Fair Value Measurements - Financial Assets and Liabilities Measured on a Recurring Basis (Details) - Fair Value Measurements Recurring Basis - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | $ 96,734 | $ 71,897 |
Contingent Consideration | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial liabilities | 64 | 60 |
Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 83,326 | 71,062 |
Restricted Cash (Money Market Funds) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 835 | 835 |
Corporate Notes and Commercial Paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 12,573 | |
Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 84,161 | 71,897 |
Level 1 | Contingent Consideration | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial liabilities | 0 | |
Level 1 | Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 83,326 | 71,062 |
Level 1 | Restricted Cash (Money Market Funds) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 835 | 835 |
Level 1 | Corporate Notes and Commercial Paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 0 | |
Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 12,573 | |
Level 2 | Contingent Consideration | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial liabilities | 0 | |
Level 2 | Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 0 | |
Level 2 | Restricted Cash (Money Market Funds) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 0 | |
Level 2 | Corporate Notes and Commercial Paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 12,573 | |
Level 3 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 0 | |
Level 3 | Contingent Consideration | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial liabilities | 64 | $ 60 |
Level 3 | Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 0 | |
Level 3 | Restricted Cash (Money Market Funds) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | 0 | |
Level 3 | Corporate Notes and Commercial Paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total financial assets | $ 0 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Cash Equivalents, Investments in Marketable Securities Classified as Available-for-Sale Securities and Restricted Cash (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Money Market Funds | ||
Schedule of Available-for-sale securities [Line Items] | ||
Cost | $ 83,326 | $ 71,062 |
Unrealized Gain | 0 | 0 |
Unrealized (Loss) | 0 | 0 |
Estimated Fair Value | 83,326 | 71,062 |
Corporate Notes and Commercial Paper | ||
Schedule of Available-for-sale securities [Line Items] | ||
Cost | 6,582 | |
Unrealized Gain | 0 | |
Unrealized (Loss) | 0 | |
Estimated Fair Value | 6,582 | |
Cash Equivalents | ||
Schedule of Available-for-sale securities [Line Items] | ||
Cost | 89,908 | 71,062 |
Unrealized Gain | 0 | 0 |
Unrealized (Loss) | 0 | 0 |
Estimated Fair Value | 89,908 | 71,062 |
Investment in Marketable Securities | ||
Schedule of Available-for-sale securities [Line Items] | ||
Cost | 5,991 | |
Unrealized Gain | 0 | |
Unrealized (Loss) | 0 | |
Estimated Fair Value | 5,991 | |
Investment in Marketable Securities | Corporate Notes and Commercial Paper | ||
Schedule of Available-for-sale securities [Line Items] | ||
Cost | 5,991 | |
Unrealized Gain | 0 | |
Unrealized (Loss) | 0 | |
Estimated Fair Value | 5,991 | |
Restricted Cash | ||
Schedule of Available-for-sale securities [Line Items] | ||
Cost | 835 | 835 |
Unrealized Gain | 0 | 0 |
Unrealized (Loss) | 0 | 0 |
Estimated Fair Value | 835 | 835 |
Restricted Cash | Restricted Cash (Money Market Funds) | ||
Schedule of Available-for-sale securities [Line Items] | ||
Cost | 835 | 835 |
Unrealized Gain | 0 | 0 |
Unrealized (Loss) | 0 | 0 |
Estimated Fair Value | $ 835 | $ 835 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Changes in the Estimated Fair Value of Contingent Consideration (Details) - Contingent Consideration $ in Thousands | 6 Months Ended |
Jun. 30, 2019USD ($) | |
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | |
Beginning balance | $ 60 |
Change in fair value of the contingent consideration liability | 4 |
Ending balance | $ 64 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventory (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Raw Materials | $ 3,911 | $ 2,851 |
Work in process | 15,587 | 1,576 |
Finished goods | 3,300 | 1,244 |
Total | $ 22,798 | $ 5,671 |
Inventory - Schedule of Balance
Inventory - Schedule of Balance Sheet Classification (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 | |
Inventory Disclosure [Abstract] | |||
Inventory | $ 4,333 | $ 1,659 | [1] |
Inventory, non-current | 18,465 | 4,012 | [1] |
Total | $ 22,798 | $ 5,671 | |
[1] | The consolidated balance sheet as of December 31, 2018 has been derived from the audited consolidated balance sheet included in the Company’s 2018 Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2019. |
Inventory - Additional Informat
Inventory - Additional Information (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 | |
Inventory [Line Items] | |||
Prepayment made for manufacturing services | $ 6,748 | $ 7,906 | [1] |
Contract Manufacturing Organization | |||
Inventory [Line Items] | |||
Prepayment made for manufacturing services | $ 6,300 | $ 6,600 | |
[1] | The consolidated balance sheet as of December 31, 2018 has been derived from the audited consolidated balance sheet included in the Company’s 2018 Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2019. |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 | |
Property Plant And Equipment [Line Items] | |||
Total property and equipment | $ 20,048 | $ 19,697 | |
Accumulated depreciation and amortization | (14,402) | (13,037) | |
Property and equipment, net | 5,646 | 6,660 | [1] |
Machinery and Equipment | |||
Property Plant And Equipment [Line Items] | |||
Total property and equipment | 11,676 | 11,505 | |
Computer Equipment and Software | |||
Property Plant And Equipment [Line Items] | |||
Total property and equipment | 2,880 | 1,651 | |
Furniture and Fixtures | |||
Property Plant And Equipment [Line Items] | |||
Total property and equipment | 714 | 714 | |
Leasehold Improvements | |||
Property Plant And Equipment [Line Items] | |||
Total property and equipment | 4,364 | 4,364 | |
Construction in Progress | |||
Property Plant And Equipment [Line Items] | |||
Total property and equipment | $ 414 | $ 1,463 | |
[1] | The consolidated balance sheet as of December 31, 2018 has been derived from the audited consolidated balance sheet included in the Company’s 2018 Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2019. |
Balance Sheet Components - Addi
Balance Sheet Components - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Property Plant And Equipment [Abstract] | ||||
Depreciation and amortization | $ 674 | $ 902 | $ 1,365 | $ 1,824 |
Balance Sheet Components - Sc_2
Balance Sheet Components - Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 | |
Payables And Accruals [Abstract] | |||
Accrued clinical and manufacturing | $ 4,884 | $ 3,950 | |
Accrued other | 3,411 | 3,058 | |
Accrued liabilities | $ 8,295 | $ 7,008 | [1] |
[1] | The consolidated balance sheet as of December 31, 2018 has been derived from the audited consolidated balance sheet included in the Company’s 2018 Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2019. |
Revenue - Additional Informatio
Revenue - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Revenue From Contract With Customer [Abstract] | ||||
Net product revenue | $ 83,433,000 | $ 0 | $ 120,531,000 | $ 0 |
Revenue - Revenue by Significan
Revenue - Revenue by Significant Customer (Details) - Net Product Revenue - Customer Concentration Risk | 3 Months Ended | 6 Months Ended |
Jun. 30, 2019 | Jun. 30, 2019 | |
Disaggregation Of Revenue [Line Items] | ||
Percentage of total revenue | 100.00% | 100.00% |
McKesson | ||
Disaggregation Of Revenue [Line Items] | ||
Percentage of total revenue | 42.00% | 43.00% |
AmeriSource-Bergen Corp | ||
Disaggregation Of Revenue [Line Items] | ||
Percentage of total revenue | 31.00% | 32.00% |
Cardinal | ||
Disaggregation Of Revenue [Line Items] | ||
Percentage of total revenue | 25.00% | 23.00% |
Others | ||
Disaggregation Of Revenue [Line Items] | ||
Percentage of total revenue | 2.00% | 2.00% |
Revenue - Activities and Ending
Revenue - Activities and Ending Reserve Balances for Each Significant Category of Discounts and Allowances (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2019USD ($) | |
Accounts Notes And Loans Receivable [Line Items] | |
Balance at December 31, 2018 | $ 0 |
Activity related to 2019 sales | 97,162 |
Payments and customer credits issued | (53,155) |
Balance at June 30, 2019 | 44,007 |
Chargebacks and Discounts for Prompt Payment | |
Accounts Notes And Loans Receivable [Line Items] | |
Balance at December 31, 2018 | 0 |
Activity related to 2019 sales | 65,726 |
Payments and customer credits issued | (42,368) |
Balance at June 30, 2019 | 23,358 |
Rebates | |
Accounts Notes And Loans Receivable [Line Items] | |
Balance at December 31, 2018 | 0 |
Activity related to 2019 sales | 8,593 |
Payments and customer credits issued | (1,095) |
Balance at June 30, 2019 | 7,498 |
Other Fees, Co-pay Assistance and Returns | |
Accounts Notes And Loans Receivable [Line Items] | |
Balance at December 31, 2018 | 0 |
Activity related to 2019 sales | 22,843 |
Payments and customer credits issued | (9,692) |
Balance at June 30, 2019 | $ 13,151 |
Convertible Notes and Term Lo_3
Convertible Notes and Term Loan - Convertible Notes - Additional Information (Details) | Feb. 29, 2016USD ($)d$ / sharesshares | Jun. 30, 2019USD ($)$ / shares | Jun. 30, 2018USD ($) | Jun. 30, 2019USD ($)$ / shares | Jun. 30, 2018USD ($) |
KKR Member | |||||
Debt Instrument [Line Items] | |||||
Aggregate principal amount | $ 20,000,000 | ||||
MX II Member | |||||
Debt Instrument [Line Items] | |||||
Aggregate principal amount | 4,000,000 | ||||
KMGCP Member | |||||
Debt Instrument [Line Items] | |||||
Aggregate principal amount | 1,000,000 | ||||
HRP III Member | |||||
Debt Instrument [Line Items] | |||||
Aggregate principal amount | 75,000,000 | ||||
8.2% Senior Convertible Notes Due March 2022 | |||||
Debt Instrument [Line Items] | |||||
Aggregate principal amount | $ 100,000,000 | ||||
Convertible notes, interest rate | 8.20% | ||||
Convertible notes, interest rate description | The Convertible Notes bear interest at a fixed coupon rate of 8.2% per annum payable quarterly in arrears on March 31, June 30, September 30 and December 31 of each year, which commenced on March 31, 2016 | ||||
Debt instrument maturity date | Mar. 31, 2022 | ||||
Convertible notes, premium percentage | 9.00% | ||||
Common shares at conversion | shares | 44.7387 | ||||
Conversion price per common share | $ / shares | $ 22.35 | ||||
Principal amount of notes converted into shares | $ 1,000 | ||||
Percentage of applicable conversion price | 160.00% | ||||
Convertible trading days | d | 20 | ||||
Convertible consecutive trading days | d | 30 | ||||
Percentage to pay in cash of the par value of notes | 109.00% | ||||
Convertible notes, covenant compliance | As of June 30, 2019, the Company was in full compliance with these covenants and there were no events of default under the Convertible Notes. | ||||
Convertible notes, converted amount | $ 98,900,000 | ||||
Closing stock, price per share | $ / shares | $ 22.10 | $ 22.10 | |||
Unamortized debt discount and debt issuance costs on Convertible Notes | $ 5,112,000 | $ 5,112,000 | |||
Amortized effective interest rate convertible notes period | 2 years 9 months | ||||
Convertible notes, effective interest rate | 9.48% | 9.48% | |||
Total interest expense related to accrued interest and amortization of debt discount | $ 2,500,000 | $ 2,400,000 | $ 4,900,000 | $ 4,800,000 |
Convertible Notes and Term Lo_4
Convertible Notes and Term Loan - Components of Convertible Notes (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 | Feb. 29, 2016 | |
Debt Instrument [Line Items] | ||||
Convertible Notes | $ 77,916 | $ 77,319 | [1] | |
Convertible Notes - related parties | 25,972 | 25,773 | [1] | |
8.2% Senior Convertible Notes Due March 2022 | ||||
Debt Instrument [Line Items] | ||||
Principal amount of the Convertible Notes | $ 100,000 | |||
Unamortized debt discount and debt issuance costs | (5,112) | |||
Total Convertible Notes | 103,888 | 103,092 | ||
8.2% Senior Convertible Notes Due March 2022 | Related Party Debt | ||||
Debt Instrument [Line Items] | ||||
Principal amount of the Convertible Notes | 27,250 | 27,250 | ||
Unamortized debt discount and debt issuance costs | (1,278) | (1,477) | ||
Convertible Notes - related parties | 25,972 | 25,773 | ||
8.2% Senior Convertible Notes Due March 2022 | Parent Company | ||||
Debt Instrument [Line Items] | ||||
Principal amount of the Convertible Notes | 81,750 | 81,750 | ||
Unamortized debt discount and debt issuance costs | (3,834) | (4,431) | ||
Convertible Notes | $ 77,916 | $ 77,319 | ||
[1] | The consolidated balance sheet as of December 31, 2018 has been derived from the audited consolidated balance sheet included in the Company’s 2018 Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2019. |
Convertible Notes and Term Lo_5
Convertible Notes and Term Loan - Components of Interest Expense on Convertable Notes (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Debt Instrument [Line Items] | ||||
Accretion of debt discount and debt issuance costs | $ 1,127 | $ 725 | ||
Interest expense | $ 613 | $ 604 | 1,224 | 1,206 |
Total interest expense | 4,433 | 2,417 | 8,649 | 4,825 |
8.2% Senior Convertible Notes Due March 2022 | ||||
Debt Instrument [Line Items] | ||||
Interest expense | 2,500 | 2,400 | 4,900 | 4,800 |
Total interest expense | 2,453 | 2,417 | 4,896 | 4,825 |
8.2% Senior Convertible Notes Due March 2022 | Related Party Debt | ||||
Debt Instrument [Line Items] | ||||
Stated coupon interest | 512 | 512 | 1,025 | 1,025 |
Accretion of debt discount and debt issuance costs | 101 | 92 | 199 | 181 |
Interest expense | 613 | 604 | 1,224 | 1,206 |
8.2% Senior Convertible Notes Due March 2022 | Parent Company | ||||
Debt Instrument [Line Items] | ||||
Stated coupon interest | 1,538 | 1,538 | 3,075 | 3,075 |
Accretion of debt discount and debt issuance costs | 302 | 275 | 597 | 544 |
Interest expense | $ 1,840 | $ 1,813 | $ 3,672 | $ 3,619 |
Convertible Notes and Term Lo_6
Convertible Notes and Term Loan - Schedule of Future Payments on the Convertible Notes (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 | [1] |
Debt Instrument [Line Items] | |||
Total minimum payments | $ 133,600 | ||
Net carrying amount | 73,286 | $ 0 | |
8.2% Senior Convertible Notes Due March 2022 | |||
Debt Instrument [Line Items] | |||
Remainder of 2019 | 4,100 | ||
2020 | 8,200 | ||
2021 | 8,200 | ||
2022 | 111,050 | ||
Total minimum payments | 131,550 | ||
Less amount representing interest | (22,550) | ||
Convertible Notes, principal amount | 109,000 | ||
Less debt discount and debt issuance costs on Convertible Notes | (5,112) | ||
Net carrying amount | $ 103,888 | ||
[1] | The consolidated balance sheet as of December 31, 2018 has been derived from the audited consolidated balance sheet included in the Company’s 2018 Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2019. |
Convertible Notes and Term Lo_7
Convertible Notes and Term Loan - Term Loan - Additional Information (Details) - USD ($) | Jan. 07, 2019 | Jun. 30, 2019 | Jun. 30, 2019 | Dec. 31, 2021 | Dec. 31, 2019 | Jan. 01, 2020 | Feb. 29, 2016 |
Term Loan | |||||||
Debt Instrument [Line Items] | |||||||
Aggregate principal amount | $ 75,000,000 | $ 75,000,000 | |||||
Effective interest rate | 10.70% | 10.70% | |||||
Debt instrument maturity date | Jan. 7, 2025 | ||||||
Payment of closing fee to the lenders in form of origination issue discount | $ 1,100,000 | ||||||
Percentage required to pay an additional exit fee on principal amount | 4.00% | ||||||
Consolidated net sales, 2020 | $ 125,000,000 | ||||||
Consolidated net sales, thereafter | 150,000,000 | ||||||
Unamortized debt discount and debt issuance costs on Term Loan | $ 4,714,000 | $ 4,714,000 | |||||
Amortized effective interest rate Term Loan period | 5 years 6 months | ||||||
Total interest expense related to Term Loan's accrued interest and amortization of debt discount | $ 1,980,000 | $ 3,753,000 | |||||
Term Loan | Paid on or Prior to the Three Year Anniversary of Closing Date | |||||||
Debt Instrument [Line Items] | |||||||
Prepayment premium, description | with respect to any prepayment paid or required to be paid on or prior to the three year anniversary of the Credit Agreement Closing Date, 5.00% of the Borrowings prepaid or required to be prepaid, plus all required interest payments that would have been due on the Borrowings prepaid or required to be prepaid through and including the three year anniversary of the Term Loan Closing Date | ||||||
Prepayment premium percentage | 5.00% | 5.00% | |||||
Term Loan | Paid after the Three Year but on or Prior to the Four Year Anniversary of Closing Date | |||||||
Debt Instrument [Line Items] | |||||||
Prepayment premium, description | with respect to any prepayment paid or required to be paid after the three year anniversary of the Term Loan Closing Date but on or prior to the four year anniversary of the Term Loan Closing Date, 5.00% of the Borrowings prepaid or required to be prepaid | ||||||
Prepayment premium percentage | 5.00% | 5.00% | |||||
Term Loan | Paid after the Four Year but on or Prior to the Five Year Anniversary of Closing Date | |||||||
Debt Instrument [Line Items] | |||||||
Prepayment premium, description | with respect to any prepayment paid or required to be paid after the four year anniversary of the Term Loan Closing Date but on or prior to the five year anniversary of the Term Loan Closing Date, 2.50% of the Borrowings prepaid or required to be prepaid | ||||||
Prepayment premium percentage | 2.50% | 2.50% | |||||
Term Loan | Paid Thereafter | |||||||
Debt Instrument [Line Items] | |||||||
Prepayment premium, description | with respect to any prepayment paid or required to be prepaid thereafter, 1.25% of the Borrowings prepaid or required to be prepaid | ||||||
Prepayment premium percentage | 1.25% | 1.25% | |||||
Term Loan | Minimum | |||||||
Debt Instrument [Line Items] | |||||||
Consolidated net sales, 2019 | $ 70,000,000 | ||||||
Term Loan | LIBOR | |||||||
Debt Instrument [Line Items] | |||||||
Effective interest rate | 7.00% | ||||||
Term Loan | Scenario Forecast | |||||||
Debt Instrument [Line Items] | |||||||
Net sales | $ 250,000,000 | ||||||
Term Loan | Scenario Forecast | Maximum | |||||||
Debt Instrument [Line Items] | |||||||
Net sales | $ 375,000,000 | ||||||
Term Loan | Scenario Forecast | LIBOR | |||||||
Debt Instrument [Line Items] | |||||||
Effective interest rate | 6.75% | ||||||
HRP III Member | |||||||
Debt Instrument [Line Items] | |||||||
Aggregate principal amount | $ 75,000,000 | ||||||
HRP III Member | Term Loan | |||||||
Debt Instrument [Line Items] | |||||||
Term loan facility term | 6 years | ||||||
Aggregate principal amount | $ 75,000,000 |
Convertible Notes and Term Lo_8
Convertible Notes and Term Loan - Components of Term Loan (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 | [1] |
Debt Instrument [Line Items] | |||
Net carrying amount | $ 73,286 | $ 0 | |
Term Loan | |||
Debt Instrument [Line Items] | |||
Principal amount of the Term Loan | 75,000 | ||
Unamortized debt discount and debt issuance costs | (1,714) | ||
Net carrying amount | $ 73,286 | ||
[1] | The consolidated balance sheet as of December 31, 2018 has been derived from the audited consolidated balance sheet included in the Company’s 2018 Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2019. |
Convertible Notes and Term Lo_9
Convertible Notes and Term Loan - Components of Interest Expense on Term Loan (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2019 | Jun. 30, 2018 | |
Debt Instrument [Line Items] | |||
Accretion of debt discount and debt issuance costs | $ 1,127 | $ 725 | |
Term Loan | |||
Debt Instrument [Line Items] | |||
Stated coupon interest | $ 1,801 | 3,421 | |
Accretion of debt discount and debt issuance costs | 179 | 332 | |
Interest expense | $ 1,980 | $ 3,753 |
Convertible Notes and Term L_10
Convertible Notes and Term Loan - Schedule of Future Payments on the Term Loan (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 | [1] |
Debt Instrument [Line Items] | |||
Total minimum payments | $ 133,600 | ||
Net carrying amount | 73,286 | $ 0 | |
Term Loan | |||
Debt Instrument [Line Items] | |||
Remainder of 2019 | 3,641 | ||
2020 | 7,244 | ||
2021 | 7,224 | ||
2022 | 7,224 | ||
2023 | 39,346 | ||
2024 and beyond | 47,495 | ||
Total minimum payments | 112,174 | ||
Less amount representing interest | (34,174) | ||
Term Loan, gross | 78,000 | ||
Less debt discount and debt issuance costs on Convertible Notes | (4,714) | ||
Net carrying amount | $ 73,286 | ||
[1] | The consolidated balance sheet as of December 31, 2018 has been derived from the audited consolidated balance sheet included in the Company’s 2018 Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2019. |
Commitments and Contingencies -
Commitments and Contingencies - Schedule of Contractual Obligations Under Terms of Agreements (Details) $ in Thousands | Jun. 30, 2019USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
Remainder of 2019 | $ 9,845 |
2020 | 24,975 |
2021 | 600 |
2022 | 600 |
Total obligations | $ 36,020 |
Commitments and Contingencies_2
Commitments and Contingencies - Additional Information (Details) | May 02, 2019 |
Amgen | |
Loss Contingencies [Line Items] | |
Royalty payment term | 5 years |
Leases - Additional Information
Leases - Additional Information (Details) $ in Millions | 1 Months Ended | 3 Months Ended | 6 Months Ended | |
Jul. 31, 2015USD ($)ft² | Jun. 30, 2019USD ($) | Jun. 30, 2019USD ($)Facility | Dec. 31, 2018USD ($) | |
Lessee Lease Description [Line Items] | ||||
Area of office space leased | ft² | 40,341 | |||
Number of laboratory facility structure | Facility | 2 | |||
Operating lease, costs | $ 0.5 | $ 1.1 | ||
Cash paid for amounts included in measurement of lease liabilities | $ 0.7 | $ 1.3 | ||
Weighted average remaining lease term | 3 years 4 months 24 days | 3 years 4 months 24 days | ||
Weighted average operating discount rate | 7.00% | 7.00% | ||
Corporate Headquarters Lease | ||||
Lessee Lease Description [Line Items] | ||||
Aggregate tenant improvement allowance | $ 1.4 | |||
Lease expiration date | Nov. 30, 2022 | |||
Leases extended expiration period | 5 years | |||
New Lease Agreement | Letter of Credit | ||||
Lessee Lease Description [Line Items] | ||||
Letter of credit amount | $ 0.8 | $ 0.8 | $ 0.8 | $ 0.8 |
Laboratory Facilities Lease | ||||
Lessee Lease Description [Line Items] | ||||
Extended lease term date one | Jun. 30, 2020 | |||
Extended lease term date two | Dec. 31, 2020 |
Leases - Schedule of Balance Sh
Leases - Schedule of Balance Sheet Classification of Lease Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Jan. 01, 2019 | Dec. 31, 2018 | [1] |
Operating lease liabilities | ||||
Other liabilities | $ 2,198 | |||
Lease liabilities, non-current | 5,977 | $ 9,200 | $ 0 | |
Total operating lease liabilities | $ 8,175 | |||
[1] | The consolidated balance sheet as of December 31, 2018 has been derived from the audited consolidated balance sheet included in the Company’s 2018 Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2019. |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Operating Lease Liabilities (Details) $ in Thousands | Jun. 30, 2019USD ($) |
Operating Lease Liabilities Payments Due [Abstract] | |
Remainder of 2019 | $ 1,333 |
2020 | 2,695 |
2021 | 2,672 |
2022 | 2,518 |
Total lease payments | 9,218 |
Less imputed interest | (1,043) |
Operating lease liabilities | $ 8,175 |
Common Stock and Stock-Based _3
Common Stock and Stock-Based Compensation - Additional Information (Details) - USD ($) | Oct. 28, 2016 | Jan. 31, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 |
Inventory | |||||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||||||
Stock-based compensation capitalized | $ 500,000 | $ 0 | $ 800,000 | $ 0 | |||
At-the-Market Equity Offering Program | |||||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||||||
Common stock, shares issued and sold | 761,130 | ||||||
Common stock, net proceeds | $ 8,200,000 | ||||||
At-the-Market Equity Offering Program | Cowen and Company LLC | |||||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||||||
Maximum amount of sales that agent may sell in shares of its common stock | $ 100,000,000 | ||||||
Percentage of gross sales proceeds of common stock payable as compensation | 3.00% | ||||||
Common stock, shares issued and sold | 761,130 | ||||||
Share price | $ 11.17 | ||||||
Gross proceeds from issuance of common stock | $ 8,500,000 | ||||||
Offering expense | 300,000 | ||||||
Common stock, net proceeds | $ 8,200,000 |
Common Stock and Stock-Based _4
Common Stock and Stock-Based Compensation - Schedule of Stock-Based Compensation Expense Recorded Related to Options and Restricted Stock Units (Details) - Employees and Nonemployees Stock Option and Restricted Stock Units - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | $ 7,991 | $ 8,690 | $ 17,486 | $ 17,410 |
Research and Development Expense | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | 2,963 | 4,072 | 6,622 | 7,835 |
Selling, general and administrative Expense | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | $ 5,028 | $ 4,618 | $ 10,864 | $ 9,575 |
Net Income (Loss) Per Share A_3
Net Income (Loss) Per Share Attributable to Coherus - Computation of Basic and Diluted Net Income (Loss) Per Share Attributable to the Company (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2018 | Mar. 31, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Numerator: | ||||||
Net income (loss) attributable to Coherus | $ 23,567 | $ (20,004) | $ (43,638) | $ (44,297) | $ 3,563 | $ (87,935) |
Denominator: | ||||||
Weighted-average common shares outstanding | 69,479,016 | 63,960,567 | 69,310,791 | 62,051,912 | ||
Basic net income (loss) per share attributable to Coherus | $ 0.34 | $ (0.68) | $ 0.05 | $ (1.42) | ||
Numerator: | ||||||
Net income (loss) attributable to Coherus | $ 23,567 | $ (20,004) | $ (43,638) | $ (44,297) | $ 3,563 | $ (87,935) |
Denominator: | ||||||
Denominator for basic net income (loss) per share attributable to Coherus | 69,479,016 | 63,960,567 | 69,310,791 | 62,051,912 | ||
Add effect of potential dilutive securities: | ||||||
Stock options | 3,469,172 | 0 | 2,953,049 | 0 | ||
Restricted stock units | 15,784 | 0 | 17,724 | 0 | ||
Denominator for diluted net income (loss) per share attributable to Coherus | 72,963,972 | 63,960,567 | 72,281,564 | 62,051,912 | ||
Diluted net income (loss) per share attributable to Coherus | $ 0.32 | $ (0.68) | $ 0.05 | $ (1.42) |
Net Income (Loss) Per Share A_4
Net Income (Loss) Per Share Attributable to Coherus - Outstanding Dilutive Potential Shares Excluded from Calculation of Diluted Net Income (Loss) Per Share Attributable to Coherus (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from the calculation of diluted net loss per share | 14,815,669 | 18,490,771 | 14,669,249 | 18,490,771 |
Stock Options, Including Purchases from Contributions to ESPP | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from the calculation of diluted net loss per share | 10,341,798 | 13,901,836 | 10,195,378 | 13,901,836 |
Restricted Stock Units | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from the calculation of diluted net loss per share | 0 | 115,064 | 0 | 115,064 |
Shares Issuable Upon Conversion of Convertible Notes | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from the calculation of diluted net loss per share | 4,473,871 | 4,473,871 | 4,473,871 | 4,473,871 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 | Feb. 29, 2016 | ||
Related Party Transaction [Line Items] | |||||||
Research and development expense | $ 18,883,000 | $ 26,519,000 | $ 37,672,000 | $ 51,974,000 | |||
Accounts payable - related parties | 50,000 | 50,000 | $ 0 | [1] | |||
Selling, general and administrative expenses from transactions with related party | 1,000 | 66,000 | 1,000 | 100,000 | |||
Medpace Inc | |||||||
Related Party Transaction [Line Items] | |||||||
Research and development expense | 0 | 1,500,000 | |||||
Board of Directors | Recruiting Services | |||||||
Related Party Transaction [Line Items] | |||||||
Research and development expense | 50,000 | 0 | 50,000 | 0 | |||
Accounts payable - related parties | 50,000 | 50,000 | $ 0 | ||||
Selling, general and administrative expenses from transactions with related party | $ 1,000 | $ 60,000 | $ 1,000 | $ 100,000 | |||
Affiliated Entity | |||||||
Related Party Transaction [Line Items] | |||||||
Aggregate principal amount | $ 25,000,000 | ||||||
[1] | The consolidated balance sheet as of December 31, 2018 has been derived from the audited consolidated balance sheet included in the Company’s 2018 Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2019. |